On July 29, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its financial results for the first half of 2021 (Press release, Ipsen, JUL 29, 2021, View Source [SID1234585319]):

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Strong financial results
Total sales growth in H1 2021 of 11.0% at CER1, or 6.5% as reported, to €1,350.3m
Q2 2021 total sales growth of 16.8% at CER1, or 12.7% as reported, to €691.8m
Core operating income of €479.8m (H1 2020: €410.2m); IFRS operating income of €412.2m (H1 2020: €249.8m)
Core operating margin2: 35.5% (H1 2020: 32.3%). IFRS operating margin: 30.5% (H1 2020: 19.7%)
Healthy balance sheet: net debt down to €336.5m, a reduction of €188.7m versus December 2020
Delivering against the strategy
Maximizing the brands:
Speciality Care sales growth in H1 2021 of 11.2%1 to €1,244.5m
Consumer Healthcare sales growth in H1 2021 of 8.6%1 to €105.9m
Strengthening the pipeline:
Good progress in external innovation: agreements announced in early and mid-stage pipeline
Regulatory submission acceptance for palovarotene in FOP3 in the U.S. and E.U.
Regulatory approval and launch of first-line renal cell carcinoma indication for Cabometyx (cabozantinib) in combination with nivolumab and positive Phase III results for Cabometyx in differentiated thyroid cancer
Driving efficiencies:
Cost savings driven by reduced face-to-face activity as a result of the pandemic, and by some efficiency gains
Ratio of SG&A expenses to total sales declined to 35.8% (H1 2020: 37.0%)
Focus on culture:
Strong momentum with Ipsen’s ambitious CSR4 agenda
Full-year guidance upgraded
Total sales growth: greater than +8.0%1 (prior guidance: greater than +4.0%1)
Core operating margin: around 32.0% (prior guidance: greater than 30.0%)
David Loew, Chief Executive Officer, commented:
"Our strong results reflected the progress we are making with our new strategy. We continued to grow our brands, with particularly strong sales in the second quarter partly a result of the gradual lifting of pandemic confinement measures. We achieved the important regulatory approval and launch of the combination of Cabometyx with nivolumab in first-line renal cell carcinoma and, while we were disappointed with the recent Phase III data readout in liver cancer, our pipeline continued to strengthen, with the positive Phase III results for Cabometyx in thyroid cancer and the regulatory submission of palovarotene in FOP. This progress was coupled with recent licensing agreements in the early and mid-stage pipeline. I was also pleased with the efficiencies achieved throughout our business, with the focus on our culture also underpinning more exciting opportunities to benefit patients and society.

Our raised expectations for our full-year results reflect the strength of our business. In the near term, we await further regulatory steps for palovarotene in the U.S. and Europe, while we continue to anticipate launches of generic lanreotide in Europe this year. I expect Ipsen to continue to deliver, driven by a clear strategy, strong fundamentals and attractive growth opportunities, reinforced by an unrelenting focus on serving patients."

Total sales growth in H1 2021 of 11.0% at CER6, or 6.5% as reported, to €1,350.3m. This included an increase in Specialty Care sales of 11.2%6 to €1,244.5m, driven by the growth of Cabometyx, Decapeptyl (triptorelin), Somatuline (lanreotide) and Dysport (botulinum toxin type A). Consumer Healthcare sales growth of 8.6%6 to €105.9m was partly a result of the reducing effects of the COVID-19 pandemic, particularly in China
Core operating income of €479.8m, up by 17.0%, partly reflected the strong growth in total sales and other revenue. The increase in SG&A costs to €483.4m was limited to 3.0%, with cost savings realized in selling expenses, a result of reduced travel, the full effect of virtual conferences and medical meetings, as well as efficiency gains from procurement savings, project prioritization, digital initiatives and manufacturing optimization
Core operating margin of 35.5%, an increase of 3.2 percentage points versus the first half of 2020
Core consolidated net profit of €359.8m, with growth of 21.2% reflecting the aforementioned increase in core operating income. Core EPS (fully diluted) grew by 21.3% to reach €4.31
IFRS operating income of €412.2m after amortization of intangible assets, impairment losses and other operating expenses. An IFRS operating income margin of 30.5% represented an increase of 11 percentage points compared to H1 2020, when an impairment loss on the intangible assets of palovarotene was recognized, following termination of the MO-Ped Phase II trial
IFRS consolidated net profit of €303.3m represented an increase of 36.2%. IFRS EPS (fully diluted) was up by 36.5% to €3.64
Free cash flow of €291.4m represented an increase of 24.9%, mainly driven by higher operating cash flow and a reduction in current income tax
Closing net debt came to €336.5m (H1 2020: €923.3m), with the improvement in H1 2021 primarily reflecting the generation of free cash flow
FY 2021 guidance
The Company today upgrades its financial guidance for FY 2021, which incorporates an assumed progressive global recovery from COVID-19 in the second half of the year. Subsequent to the July 2021 launch of generic lanreotide in Germany, further launches of generic lanreotide in Europe in the second half of the year are also assumed; Ipsen does not, however, anticipate the launch of octreotide or lanreotide generics in the U.S. in 2021.

Total sales

Growth greater than 8.0%8

Core operating margin

Around 32.0%9, excluding any potential impact of
incremental investments from external innovation

Currency impact
Based on the level of exchange rates at the end of June 2021, Ipsen anticipates an adverse impact of approximately 2% from currencies on total sales in FY 2021.

Research and development update
In May 2021, Ipsen announced that its New Drug Application for palovarotene had been accepted by the U.S. Food and Drug Administration (FDA). Palovarotene is an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation). The target regulatory action date assigned by the FDA under Priority Review status is 30 November 2021. Similar applications were accepted by the European Medicines Agency and Swissmedic.

During the period, Ipsen announced that it would exercise its option to collaborate with Exelixis on the COSMIC-311 Phase III pivotal trial of Cabometyx in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. Ipsen has an exclusive collaboration agreement with Exelixis for the commercialization of Cabometyx outside the U.S. and Japan.

In June 2021, Ipsen and Exelixis announced that COSMIC-312, the ongoing pivotal Phase III trial evaluating Cabometyx in combination with atezolizumab, versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma, met one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis. A prespecified interim analysis for the second primary endpoint of overall survival (OS), conducted at the same time as the primary analysis for PFS, showed a trend favoring the combination of Cabometyx and atezolizumab, but did not reach statistical significance. Based on this preliminary OS data, it is anticipated that the probability of reaching statistical significance at the time of the final analysis is low.

Business development
Ipsen recently announced two agreements in line with its external-innovation focus on strengthening the pipeline:

– BKX-001 (Oncology)
In July 2021, Ipsen announced a licensing agreement with BAKX Therapeutics, providing Ipsen exclusive rights to develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors.

– Mesdopetam (Neuroscience)
Earlier in July 2021, Ipsen also announced a licensing agreement with IRLAB, providing Ipsen exclusive development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist, as a potential treatment option for people living with Parkinson’s disease experiencing levodopa-induced dyskinesia.

Company Social Responsibility
Ipsen’s CSR focus is on three areas: Employees, Communities and Environment. Examples of progress in the first half are shown below:

– Employees
Ipsen has established a balanced gender-target ratio for its Global Leadership Team by 2025. A similar timeframe has been established for the Executive Leadership Team at a minimum of 35% of both genders.

– Communities
The Company’s revolving credit facility (RCF) includes a key ESG10 element. Favorable results versus ESG-based targets by Ipsen are rewarded with charitable donations, one of which was recently awarded to International Health Partners, a charity supporting people in some of the world’s most challenging places to get the medicines they need.

– Environment
Ipsen is now using 100% green electricity across its sites in U.K., Ireland and France; 88% of Ipsen’s global electricity usage is now from renewable sources. The Company is also committed to the sustainable consumption of resources and will continue to increase energy efficiency within its operations.

Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm Paris time today. Participants are encouraged to dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can be accessed here. The event ID is 8026207.

Calendar
The Company intends to publish its year-to-date and third-quarter sales update on 21 October 2021.

Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2021 (the first half or H1 2021) and the three-month period to 30 June 2021 (the second quarter or Q2 2021), compared to six-month period to 30 June 2020 (H1 2020) and the three-month period to 30 June 2020 (Q2 2020) respectively, unless stated otherwise. Commentary is based on the performance in H1 2021, unless stated otherwise.

On July 29, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the second quarter ending June 30, 2021 (Press release, PTC Therapeutics, JUL 29, 2021, View Source [SID1234585359]).

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"I am delighted to say all facets of our business made substantial progress this quarter and we anticipate having four registration-directed trials ongoing by next quarter," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "I am also proud of the execution of the global commercial team, which is driving the continued robust growth of the DMD franchise and has led us to raise our 2021 revenue guidance despite ongoing challenges from the pandemic."

Key Second Quarter and Other Corporate Updates:

The Duchenne muscular dystrophy (DMD) franchise had a total quarterly net product revenue of $102 million in the second quarter of 2021. This represents a 36% growth over the second quarter of 2020, continuing PTC’s trend of strong quarterly commercial revenues.
Translarna (ataluren) revenue growth was driven by expansion of the patient base, continued high compliance and broader access in existing geographies as well as continued geographic expansion including Russia, Central and Eastern Europe, Middle East and North Africa.
Emflaza (deflazacort) revenue growth was primarily due to new patient starts, continued high adherence and fewer discontinuations.
Evrysdi (risdiplam) received approval from the Ministry of Health Labor and Welfare in Japan in June 2021. Evrysdi is a product of a collaboration between PTC, Roche and the SMA Foundation.
Evrysdi is now approved in 54 countries.
In the U.S., more than 1800 patients are currently treated with Evrysdi, approaching 20% total market share.
Second Quarter Clinical Updates:

The registration-directed Phase 3 PTC923 phenylketonuria (PKU) trial, APHENITY, is expected to initiate in the third quarter of 2021.
PTC has multiple ongoing clinical trials, three of which are registration-directed clinical studies:
The MIT-E Phase 2/3 vatiquinone trial for mitochondrial epilepsy with data anticipated in the third quarter of 2022.
The MOVE-FA Phase 3 vatiquinone trial for Friedreich ataxia with data anticipated in 2023.
The FITE19 Phase 2/3 emvododstat trial in patients with COVID-19 is expected to be completed by year end 2021.
A Phase 1 healthy volunteer trial of the second Bio-e compound, PTC857, was recently completed and results demonstrated predictable pharmacology and no reported tolerability findings. This allows dose selection necessary to move forward to Phase 2, which we plan to initiate for amyotrophic lateral sclerosis (ALS) in the first quarter of 2022.
Results from additional cohorts are expected from the Phase 1 healthy volunteer trial of PTC518 for Huntington’s disease in the third quarter of this year. Phase 2 planning is already underway and is expected to be initiated by the end of 2021.
The Committee for Medicinal Products for Human Use (CHMP) imposed a clock stop in the aromatic L-amino acid decarboxylase deficiency (AADC-d) review process to allow for completion of its pre-approval inspections. This process is still ongoing and therefore the CHMP opinion is now expected in the fourth quarter of 2021.
For the Biologics License Application (BLA) for AADC-d, the third cannula surgery has been completed, and PTC will align with the FDA and expects to submit the BLA by the end of this year.
Second Quarter 2021 Financial Highlights:

Total revenues were $116.7 million for the second quarter of 2021, compared to total revenues of $75.2 million for the second quarter of 2020.
Total revenue includes net product revenue across the commercial portfolio of $103.1 million and royalty revenue of $13.6 million for the second quarter of 2021.
Translarna net product revenues were $52.6 million for the second quarter of 2021, compared to $38.6 million for the second 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 $49.1 million for the second quarter of 2021, compared to $36.2 million for the second quarter of 2020. These results reflect new patient prescriptions, high compliance, and fewer discontinuations.
Roche reported first half of 2021 Evrysdi sales of approximately CHF 243 million, resulting in year-to-date royalty revenue of $20.2 million. Evrysdi is a product of a collaboration between PTC, Roche and the SMA Foundation.
U.S. GAAP (generally accepted accounting principles) research and development (R&D) expenses were $125.5 million for the second quarter of 2021, compared to $176.5 million for the second quarter of 2020. The decrease in research and development expenses is primarily related to one-time charges in the second quarter of 2020 of $53.6 million for our Censa merger, as well as $41.2 million for our commercial manufacturing service agreement with MassBiologics of the University of Massachusetts Medical School, or MassBio, related to dedicated manufacturing space for our lead gene therapy program, AADC deficiency. This was partially offset by increased investment in research programs and advancement of the clinical pipeline in the second quarter of 2021.
Non-GAAP R&D expenses were $112.0 million for the second quarter of 2021, excluding $13.4 million in non-cash stock-based compensation expense, compared to $168.0 million for the second quarter of 2020, excluding $8.6 million in non-cash stock-based compensation expense.
GAAP selling, general and administrative (SG&A) expenses were $68.9 million for the second quarter of 2021, compared to $53.7 million for the second quarter of 2020. The increase reflects our continued investment to support commercial activities including expanding our commercial portfolio, including an increase in rent and related expenses associated with entering into a long-term lease for our facility located in Hopewell Township.
Non-GAAP SG&A expenses were $56.6 million for the second quarter of 2021, excluding $12.3 million in non-cash stock-based compensation expense, compared to $45.3 million for the second quarter of 2020, excluding $8.3 million in non-cash stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $0.7 million for the second quarter of 2021, compared to $7.7 million for the second 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 $118.4 million for the second quarter of 2021, compared to net loss of $181.4 million for the second quarter of 2020.
Cash, cash equivalents and marketable securities was $947.1 million at June 30, 2021, compared to $1.1 billion at December 31, 2020.
Shares issued and outstanding as of June 30, 2021 were 70,559,330.
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 $370 and $390 million.
PTC continues to anticipate GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
PTC continues to anticipate Non-GAAP R&D and SG&A expense for the full year 2021 to be between $725 and $755 million, excluding estimated non-cash, stock-based compensation expense of $100 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 table below.

Today’s Conference Call and Webcast Reminder:

PTC will host a conference call to discuss the second 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.

On July 29, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported the appointment of Chris H. Takimoto, M.D., Ph.D., F.A.C.P., to the role of Chief Medical Officer, effective today (Press release, IGM Biosciences, JUL 29, 2021, View Source [SID1234585375]). Dr. Takimoto will be responsible for global development of IGM’s clinical pipeline of proprietary IgM antibodies. He joins IGM with 30 years of experience in cancer research and development, most recently as Senior Vice President, Oncology, Gilead Sciences, Inc. Daniel S. Chen, M.D., Ph.D., will continue to assist the Company in a consulting capacity.

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"Dr. Takimoto has a proven track record of shepherding novel oncology product candidates through clinical development together with broad expertise in oncology and pharmacology gained through a distinguished industry, academic, and public service career," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We look forward to working with him and our clinical team in continuing to advance our growing clinical pipeline of IgM antibodies. We would also like to thank Dr. Chen for the significant contributions he has made to the Company, including managing the initial dose escalation portion of our Phase 1 clinical trial of IGM-2323, our CD20 x CD3 T cell engager IgM antibody for non-Hodgkin’s lymphoma, and successfully launching our Phase 1 clinical trial of IGM-8444, our Death Receptor 5 agonist IGM antibody for solid and liquid tumors, and we sincerely wish him continued success in his career."

"As the pioneers of a groundbreaking new technology, IGM Biosciences has the potential to make a real difference for patients in therapeutic areas from oncology to infectious diseases to immunology and inflammation by harnessing the power of nature’s strongest antibodies, IgMs," said Dr. Takimoto. "IGM Biosciences has solved many of the challenges historically associated with engineering and manufacturing these complex molecules, and I look forward to participating in their clinical development and helping to demonstrate their full potential."

Prior to Gilead, Dr. Takimoto served as Chief Medical Officer, since February 2016, of Forty Seven, Inc., a biotechnology company formed out of Stanford University and acquired by Gilead Sciences in 2020. From September 2010 to January 2016, Dr. Takimoto served as Vice President of Experimental Medicine Early Development, Oncology Therapeutic Area for Janssen Research and Development, LLC. From 2008 to 2010, Dr. Takimoto served as Senior Director of Translational Medicine of Ortho Biotech Oncology Research and Development. He has over thirty years of experience in industry and academia, including academic positions at the University of Texas Health Science Center at San Antonio, the National Cancer Institute, and the Uniformed Services University of the Health Sciences. He also served as a Commissioned Officer in the U.S. Public Health Service. Dr. Takimoto received a B.S. in Chemistry from Stanford University, a Ph.D. in Pharmacology from Yale University, and an M.D. from Yale University School of Medicine.

On July 29, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, August 5, 2021 to report its second quarter 2021 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, JUL 29, 2021, View Source [SID1234585391]).

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 4156527. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has priced its previously announced underwritten public offering of $1,800,000,000 aggregate principal amount of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585408]). The $1,800,000,000 offering of senior notes will include $500,000,000 aggregate principal amount of additional 2.450% senior notes due 2028 (the "Additional 2028 Notes") at a premium to yield 2.31% and $1,300,000,000 aggregate principal amount of new 2.625% senior notes due 2031 (together with the Additional 2028 Notes, the "Notes"). The Additional 2028 Notes will have the same terms as the Company’s existing 2.450% senior notes due 2028 (the "Existing 2028 Notes"), other than the issue date and the issue price. The offering is expected to close on or about August 12, 2021, subject to customary closing conditions.

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Centene intends to use the net proceeds from the offering of the Notes, together with a portion of the proceeds of certain term loans under the Company’s proposed amended and restated credit agreement and cash on hand to redeem all of its outstanding 5.375% senior notes due 2026 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.375% senior notes due 2026 (together, the "Note Redemptions"), including all premiums, accrued interest and costs and expenses related to the Note Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

The Notes will be senior unsecured obligations of the Company and will be equal in right of payment with all of the Company’s existing and future senior indebtedness and will be senior in right of payment to all of the Company’s existing and future subordinated debt. The Notes will not be guaranteed by any of the Company’s subsidiaries.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.