On February 22, 2022 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, and the American Society for Gastrointestinal Endoscopy (ASGE) reported they are working to provide colorectal cancer screening technologies in low income and underserved communities across the United States through the Medtronic Health Equity Assistance Program for colon cancer screening, with support from Amazon Web Services (AWS) (Press release, Medtronic, FEB 22, 2022, View Source [SID1234608842]). The initiative will include the donation of 50 Medtronic GI Genius intelligent endoscopy modules to endoscopy centers across the country that can potentially improve the detection of polyps that can lead to colorectal cancer. Certain types of colorectal cancer, when caught early, can have a survival rate (five year) of up to 91%; however, it remains the third most common and third deadliest cancer among adults in the United States. With these placements, there is an opportunity to potentially impact more than 350,000 patients over three years.

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The goal of this program is to increase early detection and diagnosis in underserved communities.

"Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities," said Douglas K. Rex, M.D., MASGE, president, ASGE. "Colonoscopy is critical in preventing colorectal cancer and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed."

AWS has provided computing credits that have made the funding of this program possible and continues to work with Medtronic to support the ongoing development of GI Genius and innovative future Medtronic health screening technologies that will further support Medtronic’s health equity efforts. ASGE is independently leading the application and selection process to determine the facilities that otherwise would be unable to fund this innovative solution for underserved patient populations. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.

"The crisis of health inequities cannot be solved without expanding access to healthcare technologies that put people first," said Geoff Martha, Medtronic chairman and chief executive officer. "We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care and enhance patient outcomes."

The GI Genius intelligent endoscopy module, authorized by the FDA in April 2021, detects colorectal polyps of varying shapes and sizes automatically in real time which helps diagnose and prevent colorectal cancer. It is the first-to-market, computer-aided polyp detection system powered by artificial intelligence (AI) that provides physicians with a powerful solution in the fight to screen, detect and prevent colorectal cancer and an increase of up to 14.4% absolute detection rate (ADR). Each 1% increase in ADR decreases patients’ risk of colorectal cancer by 3%.

Earlier this month, Medtronic released its Global Inclusion, Diversity and Equity Annual Report, which maps out the Company’s Zero Barriers commitment to remove barriers to opportunity — including efforts to improve access to healthcare technology. As part of this work, Medtronic introduced several initiatives in 2021 to reduce health inequities among people of color living with diabetes, including supporting the American Diabetes Association’s Technology Access Project.

"This effort is part of Medtronic’s Zero Barriers approach to building equity within our healthcare system, accelerating our innovation and helping to bring our lifesaving technologies to more patients," said Giovanni Di Napoli, president of the Medtronic Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "The program represents a continuation of Medtronic’s commitment to health equity anchored in healthcare technology."

"Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood," said Maggie Carter, global lead for social impact at AWS. "We are pleased to support Medtronic and ASGE as part of AWS’s recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most."

For more information and to apply, visit: ASGE’s program website.

About ASGE
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with almost 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit Asge.org and ValueOfColonoscopy.org for more information.

On February 22, 2022 GT Medical Technologies Inc., reported that creators of GammaTile Therapy, a Surgically Targeted Radiation Treatment for operable brain tumors, reported its 2021 roster of ELITE Distinguished Brain Tumor Specialists that have completed 10 or more GammaTile Therapy procedures in 2021 (Press release, GT Medical Technologies, FEB 22, 2022, View Source [SID1234608841]). This year’s introduction into the ELITE program includes Piedmont Atlanta Hospital, Vidant Medical Center, Emory Healthcare, and The University of Kansas Health System. These hospitals join the existing ELITE Distinguished Brain Tumor specialists awarded in 2020, including Memorial Sloan Kettering Cancer Center, M Health Fairview, HonorHealth Scottsdale Osborn Medical Center, NorthShore University HealthSystem, and Mayfield Brain & Spine.

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GammaTile ELITE institutions share GT Medical Technologies’ purpose of improving the lives of patients with brain tumors. These medical centers are each committed to excellence by putting quality of life for their patients first and embracing evidence-based innovation.

"GammaTile represents a major upgrade compared to standard radiotherapy options," said Roukoz Chamoun, MD, Neurosurgeon and Associate Professor, Department of Neurosurgery, The University of Kansas Health System in Kansas City, KS. "With GammaTile, radiation is delivered precisely where it is needed resulting in increased efficacy and minimal potential for side effects. In addition, because it is placed during surgery immediately after tumor resection, it eliminates unnecessary and potentially dangerous delay in radiation therapy."

"GammaTile allows us to treat previously untreatable patients and has allowed selected patients to achieve astonishing survival durations. At Piedmont we love having this tool in our toolbox," said Adam Nowlan, MD, MPH, Medical Director, Radiation Oncology, Piedmont Atlanta Hospital in Georgia.

GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting tumor cells, sparing healthy tissue. Patients receive their radiation treatment while going about their daily life, without the necessity of daily trips to a medical center for external radiation. Over time, the tile naturally resorbs into the adjacent tissue with no need for additional surgery to remove it. GammaTile Therapy is shown to improve local tumor control, which can extend a patient’s life. GammaTile was FDA-cleared in 2018 for recurrent brain tumors, including recurrent high-grade gliomas, glioblastomas, meningiomas, and brain metastases. In 2020, the FDA expanded that indication to include newly diagnosed malignant brain tumors.

"We are pleased to see this technology become available to patients with brain tumors across the United States, with over 60 leading institutions now offering GammaTile," said Matthew Likens, President & CEO of GT Medical Technologies. "We take great pleasure in welcoming these prestigious institutions into the GammaTile ELITE program and commend them on their commitment to innovation and quality patient care."

GT Medical Technologies was founded by five Arizona brain tumor specialists in 2017 to overcome the limitations of the current standard of care for patients with brain tumors. The treatment has since helped hundreds of patients receive life-altering cancer treatment in top brain tumor centers across the U.S. Healthcare providers can learn more by visiting View Source

On February 22, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Citi 2022 Virtual Healthcare Conference on Thursday, February 24, 2022, at 10:15 a.m. EST (Press release, Bio-Techne, FEB 22, 2022, View Source [SID1234608840]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On February 22, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an update on its recent corporate activities and outlook (Press release, Halozyme, FEB 22, 2022, View Source [SID1234608839]).

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"Our performance in the fourth quarter closed out a year of strong performance across our business highlighted by record full year revenue from royalties, growing 130% from last year driven by the continued adoption of our wave 2 partner products subcutaneous DARZALEX and Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)," said Dr. Helen Torley, president and chief executive officer. "In 2022, we look forward to building on 2021 momentum and anticipate 50% growth in our high-margin, recurring royalty revenues driven by further adoption of wave 2 products. We project further expansion and maturing of our pipeline, with 4 new targets entering Phase 1 development and at least 5 products advancing to Phase 2 or Phase 3 development. We are also excited to be starting development of a higher yield ENHANZE API as well as a new rHuPH20 with extended room temperature stability and patent protection to 2032 in Europe and 2034 in the U.S."

Fourth Quarter Partner Highlights:

In December 2021, Janssen received FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase – fijh) in combination with Kyprolis (carfilzomib) and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

In December 2021, ViiV initiated enrollment of a Phase 1 study arm to evaluate cabotegravir administered subcutaneously with ENHANZE.

In December 2021, Janssen initiated a Phase 1 clinical trial combining Janssen’s rilpivirine and ENHANZE.

In November 2021, Roche initiated a Phase 1 study combining an undisclosed therapy with ENHANZE for a new exclusive ENHANZE target.

In October 2021, Janssen’s DARZALEX FASPRO was approved by the China National Medical Products Administration for the treatment of primary light chain amyloidosis, in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients.

In October 2021, Takeda initiated a Phase 1 single-dose, single-center, open-label, three-arm study to assess the tolerability and safety of immune globulin subcutaneous (human), 20% solution with ENHANZE (TAK-881) at various infusion rates in healthy adult subjects.
Fourth Quarter Corporate Highlights:

In December 2021, the Company announced its second share repurchase program, to repurchase up to $750 million of its outstanding common stock over a three-year period. As part of the new share repurchase program, in December 2021, the Company entered into an accelerated share repurchase agreement to repurchase $150 million of common stock.

In October 2021, the Company repurchased 0.3 million shares of common stock for $10.3 million, completing its initial three-year $550 million share repurchase program that began in November 2019 one year early. Under the program the Company repurchased a total of 22.3 million shares for $550.0 million at an average price per share of $24.72.
Fourth Quarter and Full Year 2021 Financial Highlights

Revenue for the fourth quarter was $102.0 million compared to $121.7 million for the fourth quarter of 2020. The year-over-year decrease was primarily driven by a decrease in revenue under collaboration agreement and product sales, partially offset by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab). Revenue for the quarter included $62.6 million in royalties, an increase of 96% compared to $32.0 million in the prior year period.

Total revenues for the full year were $443.3 million, compared with $267.6 million in 2020, representing growth of 66% year over year.

Cost of product sales for the fourth quarter was $21.6 million, compared to $26.3 million for the fourth quarter of 2020. The year-over-year decrease was primarily driven by lower product sales, principally the sales of bulk rHuPH20 to the Company’s partners.

Cost of product sales for the full year was $81.4 million, compared to $43.4 million in 2020, primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company’s partners.

Research and development expenses for the fourth quarter were $10.1 million, compared to $7.4 million for the fourth quarter of 2020. The increase is primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets entering clinical development.

Research and development expenses for the full year were $35.7 million, compared with $34.2 million in 2020.

Selling, general and administrative expenses for the fourth quarter were $13.8 million, compared to $10.4 million for the fourth quarter of 2020. The increase was primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets.

Selling, general and administrative expenses for the full year were $50.3 million, compared with $45.7 million in 2020.

Operating Income: On a GAAP basis in the fourth quarter of 2021, operating income was $56.5 million, compared to an operating income of $77.6 million in the fourth quarter of 2020.

Operating income for the full year was $275.9 million, compared to $144.3 million in 2020.

Net Income: On a GAAP basis in the fourth quarter of 2021, net income was $66.8 million, compared with net income of $73.2 million in the fourth quarter of 2020. Non-GAAP net income was $61.3 million in the fourth quarter of 2021, compared with Non-GAAP net income of $80.9 million in the fourth quarter of 2020.1

Net income for the full year on a GAAP basis was $402.7 million or $2.74 per share, compared to a net income of $129.1 million or $0.91 per share in 2020. This year over year comparison is impacted by the one-time tax benefit of $1.05 per share in 2021 as a result of the tax valuation allowance release.

Net income for the full year on a non-GAAP basis was $294.1 million compared with $160.4 million in 2020.

Earnings per Share: On a GAAP basis in the fourth quarter of 2021, diluted earnings per share was $0.46, compared with $0.50 in the fourth quarter of 2020. On a Non-GAAP basis diluted earnings per share was $0.42, compared with diluted earnings per share of $0.56 in the fourth quarter of 2020.1

GAAP diluted earnings per share for the full year was $2.74 compared with $0.91 per share in 2020. These GAAP results included the one-time recognition of a non-cash income tax benefit during 2021 of $1.05 per share. Non-GAAP diluted earnings per share for the full year was $2.00 per share, compared to $1.12 per share in 2020.

Cash, cash equivalents and marketable securities were $740.9 million on December 31, 2021, compared to $368.0 million on December 31, 2020.
Financial Outlook for 2022

The Company is reiterating its financial guidance for 2022 first provided on January 10, 2022. For the full year 2022, the Company expects:

Total revenue of $530 million to $560 million, representing growth of 20%-26% over 2021 total revenue. The Company expects revenue from royalties to increase approximately 50% over revenue from royalties in 2021 to approximately $300 million.

GAAP operating income of $350 million to $380 million, representing growth of 27%-38% over 2021 GAAP operating income, resulting in operating margins greater than 65%.

GAAP net income of $270 million to $295 million; and non-GAAP net income of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2021 today, Tuesday, February 22, 2022 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, please register a day in advance or at minimum 10 minutes before the start of the call.

On February 22, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the fourth quarter and full year ending December 31, 2021 (Press release, PTC Therapeutics, FEB 22, 2022, View Source [SID1234608838]).

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"It is gratifying to see that after two years of investment in the innovation revenue cycle we see substantial progress across the robust pipeline and commercial revenues exceeding half a billion dollars," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "2022 is expected to be a transformational year for PTC and I look forward to continued growth."

Key 2021 Corporate Updates:

Strong revenue growth continued in the Duchenne muscular dystrophy (DMD) franchise, with total net product revenue of $423 million for Translarna (ataluren) and Emflaza (deflazacort) in 2021.
Translarna total net product revenue of $236 million was due to treatment of new patients, continued high compliance, and geographic expansion.
Emflaza total net product revenue of $187 million was driven by continued new prescriptions, continued high compliance, and more favorable access.
Evrysdi (risdiplam) 2021 revenue of over $500 million resulted in a $25 million sales-based milestone to PTC. Evrysdi is now the most prescribed Spinal Muscular Atrophy (SMA) therapy in the U.S. and growth continues in markets outside of the U.S. Evrysdi is a product of the SMA collaboration between PTC, the SMA Foundation and Roche.
Waylivra (volanesorsen) and Tegsedi (inotersen) both received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos – CMED (Drug Market Regulation Chamber) in Brazil. This allows for pricing in line with international markets.
PTC submitted an application to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), for approval of Waylivra for the treatment of familial partial lipodystrophy (FPL). If approved, Waylivra would be the first treatment in the world approved for FPL.
PTC successfully advanced the clinical pipeline in 2021:
Phase 1 healthy volunteer trial of PTC518, the next compound from the validated splicing platform, which is being developed for Huntington’s disease (HD).
Phase 1 healthy volunteer trial of PTC857, the second compound from the Bio-e platform, which is being developed for amyotrophic lateral sclerosis (ALS).
Phase 1b studies of unesbulin in both leiomyosarcoma and diffuse intrinsic pontine glioma (DIPG), two rare oncology indications.
Enrollment is complete in the MOVE-FA registration-directed trial of vatiquinone in Friedreich ataxia, with results expected in the second quarter of 2023.
2022 Potential Value-Creating Milestones:

Results are expected mid-year for Translarna Study 041.
Results are expected from the Phase 3 APHENITY trial of PTC923 in phenylketonuria (PKU) by the end of 2022.
Results from the Phase 2/3 MIT-E study of vatiquinone in mitochondrial disease associated seizures are expected in the fourth quarter of 2022.
An opinion on our marketing authorization application (MAA) for PTC-AADC is expected in April 2022 from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).
PTC remains on track to submit the biologics license application for PTC-AADC to the Food and Drug Administration in the second quarter of 2022.
PIVOT-HD, the Phase 2 study of PTC518 in HD is expected to initiate in the first quarter of 2022.
The CardinALS registration-directed Phase 2 study of PTC857 in ALS is expected to initiate in the second quarter of 2022.
Fourth Quarter and Full-Year 2021 Financial Highlights:

Total revenues were $165.2 million for the fourth quarter of 2021, compared to $118.9 million for the fourth quarter of 2020. Total revenues were $538.6 million for the full year 2021, compared to $380.8 million for the full year 2020.
Total revenue includes net product revenue across the commercial portfolio of $118.9 million for the fourth quarter of 2021 and $428.9 million for full year 2021, compared to $107.3 million for the fourth quarter of 2020 and $333.4 million for full year 2020. Total revenue also includes collaboration and royalty revenue of $46.3 million in the fourth quarter of 2021 and $109.7 million for the full year 2021, compared to $11.6 million for the fourth quarter of 2020 and $47.4 million for the full year 2020.
Translarna net product revenues were $69.7 million for the fourth quarter of 2021, compared to $69.4 million for the fourth quarter of 2020. Translarna net product revenues were $236.0 million for the full year 2021, compared to $191.9 million for the full year 2020. These results were driven by treatment of new patients, continued high compliance, and geographic expansion.
Emflaza net product revenues were $47.5 million for the fourth quarter of 2021, compared to $36.8 million for the fourth quarter of 2020. Emflaza net product revenues were $187.3 million for the full year 2021, compared to $139.0 million for the full year 2020. These results were driven by continued new prescriptions, continued high compliance, and more favorable access.
Roche reported Evrysdi full year 2021 sales of approximately CHF 602 million, resulting in full year 2021 royalty revenue of $54.6 million to PTC, as compared to $4.8 million for the full year 2020. In the first quarter of 2021 the first commercial sale of Evrysdi in the European Union triggered a $20 million milestone payment to PTC, in the third quarter of 2021 the first commercial sale of Evrysdi in Japan triggered a $10 million milestone payment from Roche to PTC, and in the fourth quarter of 2021 PTC recorded its first sales milestone of $25 million for the achievement of $500 million in worldwide annual net sales from Evrysdi. All of these 2021 achievements were reported as collaboration revenue. For the full the year 2020, the acceptance of the MAA filed by Roche for Evrysdi for the treatment of SMA triggered a $15 million milestone payment to PTC and the first commercial sale of Evrysdi in the U.S. triggered a $20 million milestone payment to PTC. Additionally, in October 2020, Chugai Pharmaceutical, Co. Ltd, a member of the Roche group, announced that a new drug application for Evrysdi for the treatment of SMA was filed in Japan. The filing in Japan triggered a $7.5 million milestone payment to PTC in the fourth quarter of 2020. PTC recognized $25 million of collaboration revenue associated with Roche milestone events in the fourth quarter of 2021 and $55 million for the full year 2021, as compared to $7.5 million in the fourth quarter of 2020 and $42.6 million for the full year 2020.
Based on U.S. GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were $149.8 million for the fourth quarter of 2021, compared to $118 million for the fourth quarter of 2020. GAAP R&D expenses were $540.7 million for the full year 2021, compared to $477.6 million for the full year 2020. The increase reflects additional investment in research programs and advancement of the clinical pipeline.
Non-GAAP R&D expenses were $136.4 million for the fourth quarter of 2021, excluding $13.4 million in non-cash, stock-based compensation expense, compared to $105.3 million for the fourth quarter of 2020, excluding $12.7 million in non-cash, stock-based compensation expense. Non-GAAP R&D expenses were $487.1 million for the full year 2021, excluding $53.6 million in non-cash, stock-based compensation expense, compared to $438.9 million for the full year 2020, excluding $38.7 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $86.5 million for the fourth quarter of 2021, compared to $75.5 million for the fourth quarter of 2020. GAAP SG&A expenses were $285.8 million for the full year 2021, compared to $245.2 million for the full year 2020. The increase reflects our continued investment to support commercial activities including expanding our commercial portfolio.
Non-GAAP SG&A expenses were $73.7 million for the fourth quarter of 2021, excluding $12.8 million in non-cash, stock-based compensation expense, compared to $66.8 million for the fourth quarter of 2020, excluding $8.7 million in non-cash, stock-based compensation expense. Non-GAAP SG&A expenses were $235.9 million for the full year 2021, excluding $49.9 million in non-cash, stock-based compensation expense, compared to $213.6 million for the full year 2020, excluding $31.6 million in non-cash, stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was a gain of $12.1 million for the fourth quarter of 2021, compared to a loss of $6.3 million for the fourth quarter of 2020. Change in the fair value of deferred and contingent consideration was a gain of $0.5 million for the full year 2021, compared to a loss of $23.3 million for the full year 2020. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
Settlement of deferred and contingent consideration was $10.6 million for the full year 2020. The settlement of deferred and contingent consideration is related to a loss upon the settlement of the deferred and contingent consideration liabilities as a result of the rights exchange agreement with certain former shareholders of Agilis, whereby such former shareholders exchanged their pro rata share of specific future cash milestone payments in the aggregate amount of $225 million for a mixture of cash and equity of PTC. Under this agreement, which the former shareholders and PTC entered into on April 29, 2020, PTC has paid $36.9 million in cash and issued 2,821,176 shares of common stock in exchange for the cancellation and forfeiture of the participating shareholders’ rights to receive (i) $174.0 million, in the aggregate, of potential milestone payments based on the achievement of certain regulatory milestones and (ii) $37.6 million, in the aggregate, of $40.0 million in development milestone payments that would have been due upon the passing of the second anniversary of the closing of PTC’s merger with Agilis, regardless of whether the milestones are achieved.
Net loss was $143.3 million for the fourth quarter of 2021, compared to net loss of $74.4 million for the fourth quarter of 2020. Net loss was $523.9 million for the full year 2021, compared to net loss of $438.2 million for the full year 2020.
Cash, cash equivalents, and marketable securities were $773.4 million on December 31, 2021, compared to $1.1 billion at December 31, 2020.
Shares issued and outstanding as of December 31, 2021 were 70,828,226.
PTC Reaffirms 2022 Financial Guidance:

PTC anticipates total revenues for the full year 2022 to be between $700 and $750 million.
PTC anticipates net product revenues for the DMD franchise for the full year 2022 to be between $475 and $495 million.
PTC anticipates GAAP R&D and SG&A expense for the full year 2022 to be between $915 and $965 million.
PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2022 to be between $800 and $850 million, excluding estimated non-cash, stock-based compensation expense of $115 million.
Non-GAAP Financial Measures:

In this press release, the financial results and financial guidance of PTC are provided in accordance with GAAP and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the tables below.

Today’s Conference Call and Webcast Reminder:

PTC will host a conference call to discuss the fourth quarter and full year of 2021 corporate updates and financial results today at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 6884452. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.