On October 28, 2021 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended September 30, 2021, highlighting commercial strength and strategic investment across clinical, product development and commercial initiatives intended to fuel future growth (Press release, NovoCure, OCT 28, 2021, View Source [SID1234592133]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). TTFields are electric fields that disrupt cancer cell division.

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(1) Adjusted EBITDA is a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and share-based compensation.

(2) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

"The third quarter was another period of solid execution at Novocure," said William Doyle, Novocure’s Executive Chairman. "We generated $134 million in net revenues and invested $48 million across our research, clinical and product development initiatives. We recently completed enrollment in our phase 3 INNOVATE-3 trial and our phase 2 EF-31 trial, and announced a new collaboration with global oncology leader, Roche. The fundamentals of our business are strong, and we are energized by the opportunities before us to help many more cancer patients and to drive the growth of our company."

"As we look ahead, we are nearing a key inflection point for patients and our organization as several of our late-stage clinical trials approach full enrollment," added Asaf Danziger, Novocure’s Chief Executive Officer. "We have completed enrollment in our INNOVATE-3 trial studying recurrent ovarian cancer, and our LUNAR trial studying non-small cell lung cancer is expected to enroll the final patient by year-end. As this cycle of late-stage trials nears conclusion, we are eager to further explore the efficacy of TTFields in new indications, together with other treatment modalities, and in partnerships with global oncology leaders."

Third quarter 2021 financial update

For the quarter ended September 30, 2021, net revenues were $133.6 million, representing 1% growth compared to the third quarter 2020.

In the United States, net revenues totaled $88.0 million in the quarter ended September 30, 2021, representing a 5% decrease compared to the same period in 2020.
In EMEA markets, net revenues totaled $30.3 million in the quarter ended September 30, 2021, representing 7% growth compared to the same period in 2020.
In Japan, net revenues totaled $8.8 million in the quarter ended September 30, 2021, representing 17% growth compared to the same period in 2020.
In Greater China, net revenues totaled $6.5 million in the quarter ended September 30, 2021, representing 52% growth compared to the same period in 2020.
For the three months ended September 30, 2021, the increase in net revenues from the third quarter of 2020 resulted primarily from an increase of 141 active patients in our currently active markets and the launch of Optune in China.

We recorded $10.6 million in revenues from Medicare fee-for-service beneficiaries in the third quarter 2021, an increase of 9% from the $9.7 million recognized in the same period in 2020. We believe we have completed the administrative ramp-up associated with processing Medicare claims and efficiently pursuing appeals. In the third quarter of 2021, we did not record a material amount of incremental net revenue resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage.

Cost of revenues for the three months ended September 30, 2021 was $30.2 million compared to $28.4 million for the same period in 2020, representing an increase of 6%. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients and increasing shipments of equipment to Zai Lab. Gross margin was 77% for the three months ended September 30, 2021 compared to 79% for the three months ended September 30, 2020.

Research, development and clinical trials expenses for the three months ended September 30, 2021 were $48.1 million compared to $32.8 million for the same period in 2020, representing an increase of 47%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal and label expansion trials, an increase in development and personnel expenses to support our product development programs, and increased investments in preclinical research and the expansion of our medical affairs activities.

Sales and marketing expenses for the three months ended September 30, 2021 were $32.6 million compared to $29.4 million for the same period in 2020, representing an increase of 11%. This was primarily due to an increase in personnel and professional services costs as we continue to enhance our commercial capabilities in anticipation of potential future approvals in new indications.

General and administrative expenses for the three months ended September 30, 2021 were $31.2 million compared to $27.1 million for the same period in 2020, representing an increase of 15%. This was primarily due to an increase in personnel costs and professional services.

Net loss for the three months ended September 30, 2021 was $13.1 million compared to net income of $9.3 million for the same period in 2020.

At September 30, 2021, we had $933.8 million in cash, cash equivalents and short-term investments, an increase of $91.2 million compared to $842.6 million at December 31, 2020. The increase in our cash, cash equivalents and short-term investments was primarily due to the cash flow from operations and the exercise of options.

Third quarter 2021 operating statistics

There were 3,502 active patients at September 30, 2021, representing 4% growth compared to September 30, 2020.

In North America, there were 2,223 active patients at September 30, 2021, representing no change compared to September 30, 2020.
In EMEA markets, there were 987 active patients at September 30, 2021, representing 9% growth compared to September 30, 2020.
In Japan, there were 292 active patients at September 30, 2021, representing 21% growth compared to September 30, 2020.
Additionally, 1,380 prescriptions were received in the quarter ended September 30, 2021, representing 1% growth compared to the same period in 2020.

In North America, 931 prescriptions were received in the quarter ended September 30, 2021, representing a 3% decrease compared to the same period in 2020.
In EMEA markets, 339 prescriptions were received in the quarter ended September 30, 2021, representing 3% growth compared to the same period in 2020.
In Japan, 110 prescriptions were received in the quarter ended September 30, 2021, representing 28% growth compared to the same period in 2020.
Third quarter 2021 non-U.S. GAAP measures

We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Adjusted EBITDA was $19.9 million for the three months ended September 30, 2021, a decrease of $17.4 million, or 47%, from $37.3 million for the three months ended September 30, 2020. The decrease was driven by increased investments in research and development activities intended to further our exploration of TTFields therapy, and in sales and marketing readiness initiatives in anticipation of future potential launches in new indications. Adjusted EBITDA as a percentage of net revenues reached 15% in the quarter, despite research and development investment reaching 36% of third quarter net revenues. We believe these focused investments are critical to our efforts to realize the long-term potential of the TTFields platform.

Recent achievements

In September, the FDA granted breakthrough device designation to the NovoTTF-200T system for the treatment of advanced liver cancer, in part based on clinical data from Novocure’s phase 2 HEPANOVA trial. Our team, along with trial investigators, are actively designing a phase 3 pivotal trial studying the efficacy of TTFields together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.
In September, we announced a clinical trial collaboration with Roche to evaluate the use of TTFields together with atezolizumab for the treatment of metastatic pancreatic cancer.
In October, we announced the last patient had been enrolled in our phase 2 pilot EF-31 trial for the treatment of gastric cancer.
Today, we announced that the last patient was enrolled in our phase 3 pivotal INNOVATE-3 trial for the treatment of recurrent ovarian cancer.
Anticipated clinical milestones

Data from phase 2 pilot EF-31 trial in gastric cancer (2022)
Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
Final data from phase 3 pivotal LUNAR trial in NSCLC (2022)
Last patient enrollment in phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal METIS trial in brain metastases (2023)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2021 financial results at 8 a.m. EDT today, Thursday, October 28, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 6394785.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 28, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2021 third quarter financial results on Tuesday, November 9, 2021, before the market opens (Press release, Eagle Pharmaceuticals, OCT 28, 2021, View Source [SID1234592149]).

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Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will host a conference call to discuss the results as follows:

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-8292 (US) or 402-220-6069 (International) and entering conference call ID EGRXQ321. The webcast will be archived for 30 days at the aforementioned URL.

On October 28, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the third quarter ended September 30, 2021, and raised full-year guidance (Press release, LabCorp, OCT 28, 2021, View Source [SID1234592080]).

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"Labcorp delivered another quarter of strong performance as we continue to leverage innovation, science and technology to accelerate our strategy," said Adam Schechter, chairman and CEO of Labcorp. "Our Base Business continued to perform well and grew 14.6%. As a result of our third-quarter performance and improved outlook for the balance of the year, we are raising our full-year financial guidance."

Labcorp’s strong execution against its strategy to improve health care progressed as the company continued its important work to help fight the pandemic. In oncology, Labcorp remained committed to its life-saving work and expanded testing, treatment and clinical trial access for people with cancer. The company intensified its customer focus and made key strides in women’s health, including the acquisition of Ovia Health, a trusted digital health platform providing family planning, pregnancy and parenting support. Additionally, Labcorp maintained its COVID-19 response by addressing testing needs and assisting in the development of vaccines and therapies.

Consolidated Results

Third Quarter Results

Revenue for the quarter was $4.06 billion, an increase of 4.3% over $3.90 billion in the third quarter of 2020. The increase was primarily due to organic growth of 3.4%, acquisitions of 0.4%, and foreign currency translation of 0.5%. The 3.4% increase in organic revenue is driven by a 10.2% increase in the company’s organic Base Business, partially offset by a (6.8%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing). Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $766.9 million, or 18.9% of revenue, compared to $1,047.1 million, or 26.9%, in the third quarter of 2020. The company recorded amortization, restructuring charges, and special items, which together totaled $140.2 million in the quarter, compared to $108.7 million during the same period in 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $907.1 million, or 22.3% of revenue, compared to $1,155.8 million, or 29.7%, in the third quarter of 2020. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing and higher personnel costs, partially offset by organic Base Business growth and LaunchPad savings.

Net earnings for the quarter were $587.3 million compared to $703.4 million in the third quarter of 2020. Diluted EPS were $6.05 in the quarter compared to $7.17 during the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.82 in the quarter compared to $8.41 in the third quarter of 2020.

Operating cash flow for the quarter was $767.3 million compared to $786.2 million in the third quarter of 2020. The decrease in operating cash flow was due to lower cash earnings, partially offset by favorable working capital. Capital expenditures totaled $117.8 million compared to $77.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $649.5 million compared to $709.0 million in the third quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $2.0 billion and $5.4 billion, respectively. During the quarter, the company invested $291.9 million on acquisitions and repurchased $300.0 million of stock representing approximately 1.1 million shares.

Year-To-Date Results

Revenue was $12.06 billion, an increase of 27.1% from $9.49 billion, in the first nine months of 2020. The increase was due to organic growth of 25.2%, acquisitions of 0.8%, and favorable foreign currency translation of 1.2%. The organic revenue increase includes a 18.2% contribution from the company’s organic Base Business and a 7.0% increase in COVID-19 Testing.

Operating income was $2,528.9 million, or 21.0% of revenue, compared to $1,152.2 million, or 12.1%, in the first nine months of 2020. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $400.0 million in the first nine months of 2021 compared to $750.2 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $2,928.9 million, or 24.3% of revenue, compared to $1,902.4 million, or 20.0%, in the first nine months of 2020. The increase in operating income and margin was primarily due to a recovery in the Base Business and higher COVID-19 Testing, partially offset by higher personnel costs.

Net earnings were $1,824.3 million compared to $617.8 million in the first nine months of 2020. Diluted EPS were $18.63 in the first nine months of 2021 compared to $6.31 during the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $21.75 in the first nine months of 2021 compared to $13.36 during the same period in 2020.

Operating cash flow was $2,412.1 million compared to $1,360.7 million in the first nine months of 2020. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $310.4 million compared to $282.3 million during the same period in 2020. As a result, free cash flow (operating cash flow less capital expenditures) was $2,101.7 million compared to $1,078.4 million in the first nine months of 2020.

Third Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.62 billion, a decrease of (3.2%) from $2.70 billion in the third quarter of 2020. The decrease was due to organic revenue of (3.9%), partially offset by acquisitions of 0.4% and favorable foreign currency translation of 0.3%. The decrease in organic revenue was due to a (9.7%) reduction from COVID-19 Testing, partially offset by a 5.8% increase in the Base Business.

Total volume (measured by requisitions) increased by 0.2% as acquisition volume contributed 0.2% and organic volume decreased by (0.1%). Organic volume was impacted by a (5.9%) decrease in COVID-19 Testing, partially offset by a 5.9% increase in Base Business. Price/mix decreased by (3.4%) due to COVID-19 Testing of (3.8%), partially offset by currency of 0.3%, and acquisitions of 0.2%. Organic Base Business volume was up 7.7% compared to last year, while price/mix was up 1.3%.

Adjusted operating income for the quarter was $774.9 million, or 29.6% of revenue, compared to $1,003.9 million, or 37.1%, in the third quarter of 2020. The decrease in adjusted operating income and adjusted operating margin was primarily due to a reduction in COVID-19 Testing and higher personnel costs, partially offset by organic Base Business growth and LaunchPad savings. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development

Revenue for the quarter was $1.46 billion, an increase of 17.5% over $1.24 billion in the third quarter of 2020. The increase was due to organic Base Business growth of 19.9%, acquisitions of 0.4%, and favorable foreign currency translation of 1.0%, partially offset by lower COVID-19 Testing performed through its Central Laboratories business of (3.5%) and divestitures of (0.3%). Drug Development’s Base Business benefited from broad-based growth, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $226.1 million, or 15.5% of revenue, compared to $209.7 million, or 16.9%, in the third quarter of 2020. Adjusted operating income grew primarily due to organic Base Business growth and LaunchPad savings, partially offset by lower COVID-19 Testing and higher personnel costs. The decline in adjusted operating margin was due to the mix impact of lower COVID-19 Testing. For comparability to peers, Drug Development excludes expense related to the Enterprise component of its bonus, which is included in unallocated corporate expense.

Net orders and net book-to-bill during the trailing twelve months were $7.77 billion and 1.34, respectively. Backlog at the end of the quarter was $14.39 billion, an increase of 15.4% compared to last year. The company expects approximately $4.93 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

Labcorp is raising 2021 full year guidance to reflect its strong third-quarter performance and improved full-year outlook. The following guidance assumes foreign exchange rates effective as of September 30, 2021, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.9%, Previous 2021 Guidance was 1.0%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.4%, Previous 2021 Guidance was 0.4%

(4) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.7%, Previous 2021 Guidance was 2.0%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 4893731. A telephone replay of the call will be available through November 11, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 4893731. A live online broadcast of Labcorp’s quarterly conference call on October 28, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through October 14, 2022.

On October 28, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the third quarter ended September 30, 2021 (Press release, Genocea Biosciences, OCT 28, 2021, View Source [SID1234592101]).

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"We continue to make significant progress. Most notably, we are very excited about our TiTAN clinical trial for GEN-011, our neoantigen-targeted peripheral T cell therapy (NPT) candidate, from which we expect to have initial data from a small subset of patients in the first quarter or early in the second quarter next year," said Chip Clark, Genocea’s President and Chief Executive Officer. "We are also pleased that our SITC (Free SITC Whitepaper) presentations will continue to showcase the neoantigen selection capabilities of our ATLAS platform, through differentiated long-term immunogenicity and clinical response data for GEN-009, our neoantigen-targeted vaccine candidate, and through its potential application to novel autoimmune disease treatments."

Operational updates

Strengthened Board of Directors

Jennifer Herron was appointed to the Company’s Board of Directors, effective September 8, 2021. Ms. Herron is currently Senior Vice President and Chief Commercial Officer at ADC Therapeutics SA ("ADCT"), leading global commercialization strategy and execution including the launch of ADCT’s first commercial product. She is a seasoned biopharmaceutical leader with extensive oncology experience.
Upcoming presentations
Festival of Biologics November 9-11, 2021 Event Details

Keynote panel discussion: What does the future of Immunotherapy hold for Oncology and Infectious Diseases
Date/Time: Tuesday, November 9, 2021 at 10:00 a.m. C.E.T.
Presentation: Unleashing the TiTANs: the GEN-011 neoantigen-targeted peripheral T cell therapy for solid tumors
Date/Time: Tuesday, November 9, 2021 at 4:50 p.m. C.E.T.
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting November 10-14, 2021 Event Details

Poster Presentation #475: GEN-011-101 (the TiTAN-1 trial): Phase 1 study to evaluate the safety, proliferation and persistence of GEN-011, an autologous neoantigen-targeted peripheral T cell therapy in solid tumors
Poster Presentation #485: Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
Poster Presentation #521: GEN-009, a personalized neoantigen vaccine candidate, elicits diverse and durable immune responses associated with clinical efficacy outcomes
Poster Presentation #753: InhibigenTM administration promotes aberrant T cell responses in cancer but may be beneficial for amelioration of autoimmune disease
Poster Presentation #248: Empiric profiling of peripheral T cell recall responses to tumor mutanomes versus in silico predictions in NSCLC patients undergoing pembrolizumab treatment ± chemotherapy
Date/Time: ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform on Friday, November 12, 2021 at 7:00 a.m. E.T.
Cellular Immunotherapies for Solid Tumors Summit November 16-18, 2021 Event Details

Presentation: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-targeted Peripheral T cells (NPTs)
Date/Time: Wednesday, November 17, 2021 at 4:30 pm E.T.
World Vaccine & Immunotherapy Congress November 30-December 2, 2021 Event Details

Panel discussion: Are neoantigens living up to their initial promise? What questions remain unanswered?
Date/Time: Wednesday, December 1, 2021 at 11:40 a.m. P.T.
Financial updates

Third quarter 2021 financial results

Cash position: As of September 30, 2021, cash and cash equivalents were $48.9 million compared to $79.8 million as of December 31, 2020.

Net loss: Net loss was $3.6 million or $0.05 diluted net loss per share for the quarter ended September 30, 2021, compared to $4.6 million or $0.26 per share for the same period in 2020. Net loss was $19.9 million or $0.54 diluted net loss per share for the nine months ended September 30, 2021, compared to $28.7 million or $1.01 per share for the same period in 2020.

Research and Development ("R&D") expenses: R&D expenses were $9.5 million for the quarter ended September 30, 2021, compared to $7.5 million for the same period in 2020. R&D expenses were $28.7 million for the nine months ended September 30, 2021, compared to $26.1 million for the same period in 2020.

The increase in R&D expenses for both periods is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.
General and Administrative ("G&A") expenses: G&A expenses were $3.9 million for the quarter ended September 30, 2021, compared to $3.6 million for the same period in 2020. G&A expenses were $11.6 million for the nine months ended September 30, 2021, compared to $10.5 million for the same period in 2020.

The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
Other income: Other income was $8.1 million for the quarter ended September 30, 2021, compared to $6.2 million for the same period in 2020. Other income was $18.8 million for the nine months ended September 30, 2021, compared to $6.5 million for the same period in 2020.
The increase in other income for both periods is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with the Company’s July 2020 private placement (the "2020 Warrants"). During the quarter ended September 30, 2021, the 2020 Warrants were remeasured to their fair value of $36.0 million and subsequently reclassified to equity.

Guidance

Genocea’s operating plan extends its cash runway into the third quarter of 2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8729366. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On October 28, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the third quarter ending September 30, 2021 (Press release, PTC Therapeutics, OCT 28, 2021, View Source [SID1234592117]).

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"The stellar growth of our DMD franchise is remarkable." said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "I continue to be impressed by the team’s performance. The commercial performance, along with the milestones achieved in Brazil, and the continued advancements in our pipeline, with initiating a fifth registration-directed trial, allows us continued value creation for all of our stakeholders."

Key Third Quarter and Other Corporate Updates:

The Duchenne muscular dystrophy (DMD) franchise grew 39% over the third quarter of 2020, demonstrating PTC’s continued strong commercial performance. Quarterly net product revenue for the franchise was $114 million in the third quarter of 2021.
Translarna (ataluren) revenue growth was driven by geographic expansion and new patient identification.
Emflaza (deflazacort) revenue growth was driven primarily by new patient starts and maintained high compliance.
Evrysdi(risdiplam) continues to show strong global uptake. The first commercial sale of Evrysdi in Japan occurred in August 2021, resulting in a $10 million milestone payment from Roche to PTC with $325 million in sales-based milestones remaining. Evrysdi is a product of a collaboration between PTC, Roche and the SMA Foundation.
Waylivra (volanesorsen) was approved by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), as the first treatment for familial chylomicronemia syndrome (FCS) in Brazil.
Tegsedi (inotersen) has successfully received Category 1 classification from CMED (Drug Market Regulation Chamber) in Brazil. Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care and allows for pricing in line with international markets.
Third Quarter Clinical Updates:

The APHENITY registration-directed Phase 3 trial for PTC923 for phenylketonuria (PKU) has been initiated with results expected by the end of 2022.
PTC continues to make progress in three additional ongoing registration-directed clinical studies:
The MIT-E Phase 2/3 vatiquinone trial for mitochondrial disease associated seizures with results anticipated in the third quarter of 2022.
The MOVE-FA Phase 3 vatiquinone trial for Friedreich ataxia with results anticipated in 2023.
Enrollment in the FITE19 Phase 2/3 emvododstat trial in patients with COVID-19 is expected to be completed by year end 2021.
The Phase 1 healthy volunteer study of PTC518 for Huntington’s disease met the objectives in the third quarter of this year. The Phase 2 study in patients with Huntington’s disease is expected to be initiated by the end of 2021.
The Committee for Medicinal Products for Human Use (CHMP) opinion on the PTC-AADC gene therapy for aromatic L-amino acid decarboxylase (AADC) deficiency is expected in the fourth quarter of 2021.
For the Biologics License Application (BLA) for AADC deficiency, PTC expects to submit the BLA in the first quarter of 2022.
Third Quarter 2021 Financial Highlights:

Total revenues were $138.7 million for the third quarter of 2021, compared to total revenues of $118.4 million for the third quarter of 2020.
Total revenue includes net product revenue across the commercial portfolio of $115.6 million and royalty and collaboration revenue of $23.1 million for the third quarter of 2021, compared to net product revenues of $82.7 million and royalty and collaboration revenues of $35.7 million for the third quarter of 2020.
Translarna net product revenues were $67.2 million for the third quarter of 2021, compared to $43.4 million for the third quarter of 2020. These results reflect an increase in net product sales in existing markets as well as continued geographic expansion.
Emflaza net product revenues were $47.1 million for the third quarter of 2021, compared to $38.5 million for the third quarter of 2020. These results reflect new patient prescriptions, high compliance, and fewer discontinuations.
Roche reported Evrysdi 2021 year to date sales of approximately CHF 396 million, resulting in year-to-date royalty revenue of $33.3 million to PTC. During the third quarter of 2021, the first commercial sale of Evrysdi in Japan triggered a $10 million milestone payment from Roche to PTC, which was reported as collaboration revenue.
U.S. GAAP (generally accepted accounting principles) research and development (R&D) expenses were $130.8 million for the third quarter of 2021, compared to $93.0 million for the third quarter of 2020. The increase reflects additional investment in research programs and advancement of the clinical pipeline.
Non-GAAP R&D expenses were $117.8 million for the third quarter of 2021, excluding $13.0 million in non-cash stock-based compensation expense, compared to $83.8 million for the third quarter of 2020, excluding $9.2 million in non-cash stock-based compensation expense.
GAAP selling, general and administrative (SG&A) expenses were $69.3 million for the third quarter of 2021, compared to $57.8 million for the third quarter of 2020. The increase reflects our continued investment to support commercial activities including expanding our commercial portfolio.
Non-GAAP SG&A expenses were $56.4 million for the third quarter of 2021, excluding $12.8 million in non-cash stock-based compensation expense, compared to $50.3 million for the third quarter of 2020, excluding $7.6 million in non-cash stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $10.8 million for the third quarter of 2021, compared to $8.4 million for the third quarter of 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.
Net loss was $133.6 million for the third quarter of 2021, compared to net loss of $69.7 million for the third quarter of 2020.
Cash, cash equivalents and marketable securities was $867.9 million at September 30, 2021, compared to $1.1 billion at December 31, 2020.
Shares issued and outstanding as of September 30, 2021 were 70,665,010.
PTC Updates Full Year 2021 Guidance as Follows:

PTC now anticipates net product revenues for the DMD franchise for the full year 2021 to be between $400 and $420 million from previous guidance of $370 and $390 million.
PTC now anticipates GAAP R&D and SG&A expense for the full year 2021 to be between $815 and $835 million from previous guidance of $825 and $855 million.
PTC now anticipates Non-GAAP R&D and SG&A expense for the full year 2021 to be between $715 and $735 million, excluding estimated non-cash, stock-based compensation expense of $100 million, from previous guidance of $725 and $755 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 third quarter 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 7064479. 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.