On July 28, 2022 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2022 and updated full-year 2022 financial guidance (Press release, West Pharmaceutical Services, JUL 28, 2022, View Source;utm_medium=Email&utm_campaign=Investors_Email&utm_content=28_July_2022&utm_source=West+Pharmaceutical+Services%2C+Inc.&utm_campaign=f7424fcbb0-EMAIL_CAMPAIGN_2022_03_31_10_50_COPY_01&utm_medium=email&utm_term=0_4b4b77d239-f7424fcbb0-584006100&ct=t(EMAIL_CAMPAIGN_5_12_2022_16_15_COPY_01)#west-announces-second-quarter-2022-results [SID1234617100]).

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Second-Quarter 2022 Summary (comparisons to prior-year period)

Net sales of $771.3 million grew 6.6%; organic net sales growth was 13.1%.
Reported-diluted EPS of $2.48, compared to $2.47 in the same period last year.
Adjusted-diluted EPS of $2.47, compared to $2.46 in the same period last year.
The Company is updating full-year 2022 net sales guidance to a range of $2.950 billion to $2.975 billion, compared to a prior range of $3.050 billion to $3.075 billion, to reflect changes in foreign currency rates and a decline in expected COVID-19 related net sales.
The Company is updating full-year 2022 adjusted-diluted EPS guidance to a new range of $9.00 to $9.15, compared to a prior range of $9.30 to $9.45.
"We delivered excellent second-quarter results with Proprietary Products organic net sales growth in the high-teens, led by demand for our high-value products (HVPs)," said Eric M. Green, President, Chief Executive Officer and Chair of the Board. "Our base business continues to be strong, reflecting our team’s successful execution of strategic initiatives and dedication to improving patient lives. In the quarter, COVID-19 related net sales slightly declined. While we expect further declines in COVID-19 related demand over the next two quarters, we also anticipate a more robust base business. We remain on track to expand our global HVP manufacturing capacity to support increased demand across our Biologics, Generics and Pharma market units."

Proprietary Products Segment
Net sales grew by 11.3% to $653.7 million. Organic net sales growth was 18.3%, with currency translation decreasing sales growth by 700 basis points. HVP sales represented over 70% of segment sales and generated double-digit organic sales growth, led by customer demand for NovaPure, Envision and Daikyo Crystal Zenith components and for self-injection devices.

The Biologics and Generics market units had double-digit organic sales growth, and the Pharma market unit had mid-single digit organic sales growth.

Contract-Manufactured Products Segment
Net sales declined by 13.6% to $117.8 million. Organic net sales declined by 8.9% with currency translation decreasing sales growth by 470 basis points. Segment sales declined primarily due to a decrease in sales of components for diagnostic devices.

Financial Highlights (first six months of 2022)
Operating cash flow was $324.3 million, an increase of 39.1%. Capital expenditures were $131.9 million, an increase of 18.2% over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $192.4 million, an increase of 58.4%.

During the first-half 2022, the Company repurchased 476,667 shares for $175.7 million at an average share price of $368.54 under its share repurchase program.

Full-Year 2022 Financial Guidance

Full-year 2022 net sales are expected to be in the range of $2.950 billion to $2.975 billion, compared to a prior guidance range of $3.050 billion to $3.075 billion.
Organic sales growth is expected to be approximately 11%, compared to a prior guidance range of 11% to 12%.
The Company expects a full-year decline in COVID-19 related sales of approximately 20%, or $85 million less than 2021 sales, compared to prior expectation of year-over-year growth. Higher base business sales are expected to partially offset the decline in COVID-19 related sales.
Net sales guidance, based on current foreign currency exchange rates, includes an estimated full-year 2022 headwind of $190 million, compared to prior guidance of a $115 million headwind.
Full-year 2022 adjusted-diluted EPS is expected to be in the range of $9.00 to $9.15, compared to a prior guidance range of $9.30 to $9.45.
The full-year adjusted-diluted EPS guidance range, based on current foreign currency exchange rates, includes an estimated headwind of $0.55, compared to a prior guidance of a $0.38 headwind.
The revised guidance includes a $0.13 EPS positive impact from first-half 2022 tax benefits from stock-based compensation.
For second-half 2022, our EPS guidance range assumes a tax rate of 23% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in first-half 2022 would provide a positive adjustment to our full-year adjusted-diluted EPS guidance.
Full-year 2022 capital spending is expected to be $380 million, unchanged from prior guidance. This includes incremental capital spending to support capacity expansions at existing HVP facilities.
Second-Quarter 2022 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. The live audio-only webcast will be made available via the Company’s Investor Relations website at https://bit.ly/3cgSM9S.

To participate and ask questions during the conference call, you must register in advance at https://bit.ly/3z4iU0g. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

A replay of the conference call and webcast will be available on the Company’s website for 30 days.

On July 28, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the Company will report first half 2022 financial and operating results on the morning of Friday, August 5, 2022 (Press release, Celyad, JUL 28, 2022, View Source [SID1234617099]).

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Following the press release, Celyad Oncology management will host a conference call that day Friday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2022 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +1 201 493 6779 (International), +: 1 877 407 9716 (United States) or +32 (0) 800 73 904 (Belgium) and ask to be joined into the Celyad Oncology SA call.

To access the live webcast and archived recording, visit the "Events" section of the Celyad Oncology website.

On July 28, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2022 (Press release, Amplia Therapeutics, JUL 28, 2022, View Source;[email protected] [SID1234617098]).

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Key Highlights from the Quarter
• Positive pre-IND meeting feedback received from US FDA;
• First site opened for recruitment in ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
• Significant progress in manufacturing and toxicology studies of AMP945.

Operations Update
During the Quarter, Amplia received positive pre-IND (Type B) feedback from the US FDA on the Company’s proposed development plans for its investigational focal adhesion kinase inhibitor, AMP945, in people with pancreatic cancer. The Company also sought FDA’s specific feedback on the design of its ACCENT clinical trial of AMP945 in first-line patients with advanced pancreatic cancer.

The FDA agreed that the available and planned pre-clinical data appear to support both the trial and a future marketing application in the proposed indication. The FDA advised that the design of the ACCENT trial, including selection of the first-line patient population and the proposed dose-escalation followed by a Simon 2-stage design, is generally acceptable. FDA also confirmed Amplia’s understanding that dose selection for the Simon 2 stage expansion phase of the trial should be based on a combined view of safety, efficacy, pharmacokinetics and pharmacodynamics across a wide range of doses.

Additionally, during the Quarter, ethics committee approval was received to conduct the trial and the first site for recruitment of patients to the ACCENT trial was opened at Monash Health in Victoria, Australia. Three additional sites are scheduled to be activated in late July/early August. Previously the Company had forecast that the first patient would be recruited to the trial in the second calendar quarter of 2022 but this target was not met, primarily due to a longer than expected timeline to finalise contracts and governance arrangements with the various clinical sites. These matters have now been resolved allowing the ACCENT trial to recruit patients as planned. In order to recover any delays caused by slower than expected clinical trial start-up, the Company is assessing additional sites, increased patient outreach options and is planning an acceleration of South Korean site activation.

The Company has continued to make progress towards the initiation of a Phase 2 clinical study in Idiopathic Pulmonary Fibrosis patients with completion of dosing in the enabling 3-month toxicology studies of AMP945. Draft reports from these studies are expected in August 2022 and the Company will inform the market of any material outcomes.

Manufacture of AMP945 drug substance for use in non-clinical and clinical studies was also conducted with higher than expected yields of AMP945 being obtained, reflecting improved manufacture process understanding. A manufacture process for AMP945 higher potency drug product capsules was also developed. By delivering doses with fewer capsules, patient convenience and adherence to clinical trial protocols will be enhanced. Ongoing stability studies of AMP945 drug substance and drug product also show that AMP945 remains within specification for extended periods of time, supporting a likely long product shelf-life.

In June, new data from preclinical studies was disclosed showing that AMP945 had comparable activity to OFEV, the current market leader in the treatment of idiopathic pulmonary fibrosis. The Company expects that this new information will encourage interest from both clinical investigators and patients.

After joining the Company in February 2021 as Director Operations, Dr Rhiannon Jones was promoted to Chief Operations Officer (COO) effective July 1, 2022. Dr Jones has been leading much of Amplia’s manufacturing activities and her promotion to this broader role is a reflection of Amplia’s growth into a more mature clinical-stage company.

Financial update
Amplia finished the June 2022 quarter with cash of $12.7 million (March 2022: $14.6 million).

During the quarter, the Company had net cash outflows of $1.8 million in relation to operating activities (March 2022: $2.3 million). Operating cashflows included outflows of:
• $0.3 million for staff and administration/corporate costs; and
• $1.2 million for research and development costs, which primarily related to toxicology studies, ACCENT trial clinical costs and manufacturing costs of AMP945 drug substance and product.

Research and development expenditure is forecast to increase in the coming quarters in line with the commencement of the Phase 2 clinical trial for AMP945, which is expected to commence recruitment in the coming weeks with the first patient expected to be dosed in July-August 2022.

Payments to Related Entities
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $102,230 and relate to payments to the CEO/Managing Director in line with Dr Lambert’s employment contract and payments to the Non-Executive Directors.

Outlook and future activities
In the coming quarter, the Company expects to report on recruitment progress in the ACCENT trial as well as updates on progression towards optimal dose selection. The Company also expects to receive draft study reports from 3-month toxicology studies and will report top-line outcomes from these studies. Work on Amplia’s second FAK inhibitor, AMP886, is ongoing and outcomes from preclinical and manufacturing development work will be provided when ongoing studies are completed.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On July 28, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo to treat patients with solid and hematologic malignancies, reported that new data at the 2022 iPSC Manufacturing Summit held in Boston, Mass. on the development of a precision genome engineered induced pluripotent stem cells (iPSCs) to incorporate a synthetic cytokine receptor, permitting more efficient differentiation and expansion of cells into functional, persistent cytotoxic cell types that is further compatible with efficient scale-up production (Press release, Umoja Biopharma, JUL 28, 2022, View Source [SID1234617094]).

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"Our newest data highlights a new way to efficiently differentiate and expand high-quality iPSCs in quantities necessary for treating more patients with potentially life-changing cell therapies," said lead author of the study and principal scientist at Umoja, Teisha Rowland, Ph.D. "Previously, scientists were limited with culturing these cells on plates, but with the new ShRED system we show that it is possible to grow cells in suspension, which is expected to translate to large-scale manufacturing. Importantly, we also showed that CAR-NK cells made using this new technique are highly functional therapeutic cells. This further validates employing our RACR technology platform to overcome critical limitations facing the cell therapy industry."

On Thursday July 28th, Principal Scientist Teisha Rowland, Ph.D., gave a presentation titled "Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up." The presentation demonstrated progress on Umoja’s iPSC platform and the development of a synthetic receptor enabled differentiation (ShRED) protocol that employs a rapamycin activated cytokine receptor (RACR) to drive differentiation and expansion of iPSCs in a controlled and consistent manner, without the addition of expensive growth factors and cytokines. Activating RACR with a rapamycin analog (rapalog) during hematopoietic progenitor (HP) generation was shown to increase HP yield controls in conventional cell culture format. Additional improvement of cell culture conditions further enhanced RACR-driven yields.

Furthermore, resultant iPSC-derived cytotoxic innate lymphocytes (RACR-iCILs) displayed improved innate cytotoxicity and serial killing in several tumor models. CAR-RACR-iCILs (cells engineered with chimeric antigen receptors) displayed potent and specific CAR-driven and innate tumor killing. Furthermore, RACR engineered NK cells demonstrated enhanced tumor control in a mouse breast cancer model. In addition, RACR-iCIL cells can be produced with high yields when grown in suspension, eliminating requirements for 2D culture that limit scale up manufacture of iPSC derived cell therapy products.

"We are continuing to advance our "off-the-shelf" iPSC therapy platform that aims to overcome major challenges in allogeneic cell therapy, including eliminating the need for toxic lymphodepletion and reducing manufacturing complexity and cost," said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "We are excited to share this new data on the development of our ShRED platform for the differentiation and expansion of iPSC-derived cells which is expected to yield a more consistent and potent product. The continued progress across our four complimentary platforms truly exemplifies Umoja’s commitment and determination towards developing curative treatments that can be delivered to any patient, with any tumor, at any time."

About RACR
CAR T cells generated by the body with VivoVec can be expanded and sustained with the rapamycin activated cytokine receptor (RACR) system, an engineered signaling system designed to improve chimeric antigen receptor (CAR) T cell persistence and produce durable anti-tumor responses. The RACR/CAR payload is integrated into the genomic DNA of a patient’s T cells. Rapamycin activates the RACR system resulting in preferential expansion and survival of cancer-fighting T cells. The RACR technology enables a patient’s cells to expand in a manner that resembles a natural immune response that does not require lymphodepletion, promoting durable T cell engraftment. RACR/CAR technology can also be used to enhance ex vivo manufacturing in support of more traditional autologous or allogeneic cell therapy manufacturing processes. To learn more about Umoja’s RACR platform please visit View Source

On July 28, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter ended June 30, 2022 and provided a corporate update for the year (Press release, Ultragenyx Pharmaceutical, JUL 28, 2022, View Source [SID1234617093]).

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"Over the last few months we continued building our commercial footprint, particularly in Latin America, raised $500 million in a capped royalty financing, and acquired GeneTx, all of which puts us in a strong position to generate meaningful value in the coming years," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "We have one of the most diverse, late-stage pipelines in rare disease, which includes our fourth pivotal gene therapy, UX111 for Sanfilippo syndrome, our pivotal program in osteogenesis imperfecta, and our promising ASO, GTX-102 in Angelman syndrome."

Second Quarter 2022 Financial Results

Net Revenues
For the second quarter of 2022, Ultragenyx reported $89.3 million in total revenue. Ultragenyx recognized $64.0 million in Crysvita (burosumab) revenue in the Ultragenyx territories, which includes $51.6 million in collaboration revenue in the North American profit share territory and net product sales in other regions of $12.4 million. Total royalty revenue related to European Crysvita sales was $5.4 million. Dojolvi (triheptanoin) product sales in the second quarter of 2022 were $13.5 million. Mepsevii (vestronidase alfa) product sales for the second quarter of 2022 were $4.9 million.

Total revenue for the second quarter of 2022 also includes $1.5 million related to technical assistance following the successful completion of technology transfer activities with Daiichi Sankyo. This compares to total revenue in the second quarter of 2021, which includes $22.0 million related to the technology transfer services which were ongoing at the time.

Operating Expenses
Total operating expenses for the second quarter of 2022 were $230.9 million, including non-cash stock-based compensation of $35.9 million.

Net Loss
For the second quarter of 2022, Ultragenyx reported net loss of $158.2 million, or $2.26 per share basic and diluted, compared with a net loss for the second quarter of 2021 of $122.4 million, or $1.81 per share, basic and diluted. Net cash used in operations for the six months ended June 30, 2022 was $194.8 million.

Cash, Cash Equivalents and Marketable Debt Securities
As of June 30, 2022, cash, cash equivalents, and marketable debt securities were $706.1 million.

In July 2022, we raised $500.0 million through the sale of 30% of our royalty interest on the future sales of Crysvita in the United States and Canada, capped at $725.0 million or 1.45x the purchase price, and we exercised our option to acquire GeneTx for $75.0 million.

2022 Financial Guidance

The company continues to expect 2022 revenue for Crysvita in Ultragenyx territories to be between $250 million and $260 million and Dojolvi revenue to be between $55 million and $65 million.

Corporate and Program Updates
Partial sale of North America Crysvita royalty
In July 2022, we sold 30% of our royalty interest in Crysvita, in the profit-share territory, to OMERS for $500.0 million, beginning in April 2023. Total payments are capped at $725.0 million, or 1.45x the purchase price, after which payments to OMERS will cease and Ultragenyx will retain the full value of the royalty.

GTX-102 for Angelman Syndrome

In July 2022, we exercised our option to acquire GeneTx and closed on the acquisition for $75.0 million plus future milestone and royalty payments. Additional milestones include $30.0 million upon achievement of the earlier of a Phase 3 clinical study start or product approvals in Canada and the U.K. We will also pay tiered royalties ranging from a mid-single to low double-digit percentage based on worldwide annual net sales.

In July 2022, we also provided an interim data and program update on patients treated in Canada and the U.K. and the U.S. under each region’s amended protocol for the Phase 1/2 study. Further details from this release can be found on the Company website.

We currently expect to provide a program update after we have determined an optimal dose and have gathered substantial data from the expansion cohorts.

UX143 (setrusumab) for Osteogenesis Imperfecta (OI)
Ultragenyx is dosing patients in the seamless Phase 2/3 Orbit study of UX143 in pediatric and adult patients with OI ages five to <26 years. A dosing update on the Phase 2 portion of the Orbit study and transition to Phase 3 is expected in the second half of 2022.

In addition, Ultragenyx intends to initiate an additional study in children with OI under age 5 years in the second half of 2022 and will continue to follow adult patients who were previously treated in the ASTEROID study, a Phase 2b study conducted by our partner Mereo.

UX111 for Sanfilippo syndrome type A (MPS IIIA)

Ultragenyx entered into an exclusive license agreement from Abeona Therapeutics for UX111 (formerly ABO-102). Under the terms of the agreement, we assumed responsibility for the UX111 program and in return Abeona is eligible to receive tiered royalties of up to 10% on net sales and commercial milestone payments following regulatory approval.

Interim results from the pivotal Transpher A clinical study were presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2022 Annual Meeting by Abeona. Additional details on this data can be found on the Company website.

DTX401 for Glycogen Storage Disease Type Ia (GSDIa): Phase 3 study dosing patients
Longer-term Phase 1/2 data were presented at ASGCT (Free ASGCT Whitepaper) 2022 Annual Meeting demonstrating a durable response from all 12 patients lasting up to more than 3.5 years following treatment with DTX401.

Dosing and enrollment of the Phase 3 study of DTX401 is ongoing. The Phase 3 study has a 48-week primary efficacy analysis period and the company plans to enroll approximately 50 patients eight years of age and older, randomized 1:1 to DTX401 or placebo. The primary endpoint is the reduction in oral glucose replacement with cornstarch while maintaining glucose control.

UX701 for Wilson Disease: Stage 1 of pivotal clinical study dosing patients
The company is dosing patients in the first stage of the Cyprus2+ study of UX701. During this stage of the study, safety and efficacy of up to three dose levels of UX701 will be evaluated and a dose will be selected for further evaluation in Stage 2. In Stage 2, a new cohort of patients will be randomized 2:1 to receive the selected dose of UX701 or placebo. The primary efficacy endpoints are change in 24-hour urinary copper concentration and percent reduction in standard of care medication by Week 52.

DTX301 for Ornithine Transcarbamylase (OTC) Deficiency: Phase 3 study expected to initiate in second half of 2022
Longer-term Phase 1/2 data were presented at the ASGCT (Free ASGCT Whitepaper) 2022 Annual Meeting showing a response from four out of five patients at the Phase 3 dose and a total of seven responders among the 11 patients enrolled in the study. This response included durable metabolic control lasting up to more than four years following treatment with DTX301 in patients with OTC deficiency.

Ultragenyx expects to initiate the Phase 3 study of DTX301 in patients with OTC in the second half of 2022. The 64-week study will include approximately 50 patients, randomized 1:1 to DTX301 or placebo. The primary endpoints are response as measured by removal of ammonia-scavenger medications and protein-restricted diet and change in 24-hour ammonia levels.

UX053 for Glycogen Storage Disease Type III (GSDIII) Debrancher Deficiency: Phase 1/2 study currently dosing patients; preliminary data from first part of study and initiation of second part of study anticipated in second half of 2022
Ultragenyx is dosing patients in the two-part Phase 1/2 clinical trial evaluating the safety, tolerability and efficacy of UX053 in adults age 18 years and older with GSDIII. Part 1 of the study is open label with single-ascending doses. Part 2 is double-blind and will evaluate repeat doses at escalating levels. We currently expect preliminary data from Part 1 of the study and to initiate Part 2 of the study in the second half of 2022.

1: Ultragenyx territories include the collaboration revenue from the North American profit share territory (U.S. and Canada) and other regions where revenue from product sales are recognized by Ultragenyx (Latin America, Turkey). This excludes the European territory revenue, which is recognized as non-cash royalty revenue since the rights were sold to Royalty Pharma in December 2019.

Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, July 28, 2022, at 2 p.m. PT/ 5 p.m. ET to discuss the second quarter 2022 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call, please register by clicking on the following link (https://register.vevent.com/register/BIfc019ed9950547e9a1a7e28d5402491f), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The replay of the call will be available for one year.