On July 19, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Company’s Board of Directors has appointed biopharmaceutical leader Corinne Le Goff, Pharm D, MBA, as President and Chief Executive Officer and Director, effective July 18, 2022 (Press release, Celsion, JUL 19, 2022, View Source [SID1234616753]). Current President and CEO Michael H. Tardugno will continue to serve as Executive Chairman of Celsion’s Board of Directors.

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Dr. Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology, vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from her tenure at both large, pharmaceutical companies and small, innovative biotech companies.

"On behalf of the Board of Directors and the entire Celsion team, I would like to warmly welcome Corinne to Celsion," said Michael H. Tardugno, Chairman of Celsion’s Board of Directors. "She adds tremendous depth of knowledge and joins us at a key inflection point in our evolution, as we work to rapidly advance our GEN-1 program for the treatment of advanced-stage ovarian cancer and build a proprietary vaccine platform based on our PLACCINE technology. Corinne’s skills and expertise in development and commercialization of therapeutics in oncology and immunology make her uniquely qualified to lead us on the next stage of growth. We look forward to her astute guidance."

Dr. Corinne Le Goff stated, "I am thrilled and honored to join as President and CEO of Celsion at this pivotal point for the Company. Celsion has an impressive portfolio of assets that address substantial unmet needs in the current vaccine and oncology landscapes. I look forward to working together with my new colleagues and the Board to realize upon the tremendous opportunities and efficiently advance these life-improving solutions for patients through clinical development, regulatory approval and commercialization."

Prior to her Celsion appointment, Dr. Corinne Le Goff most recently served as the Chief Commercial Officer of Moderna, was responsible for developing the global presence and capabilities necessary to ensure the global distribution of Moderna’s COVID-19 vaccine. She also led the development of the mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President of the U.S. Business, driving the growth strategy with increased contributions from Repatha and Aimovig. During her nearly 6-year tenure at Amgen, she also served as Senior Vice President of Global Product Strategy & Commercial Innovation and as President of the Europe Region overseeing 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality and affordable healthcare. She represented Amgen as a member of the Healthcare Leadership Council. Prior to joining Amgen, Dr. Le Goff held a number of senior international roles at Roche, including President of Roche France, a major affiliate of the Roche Group, and Global Product Strategy Head of Neuroscience & Rare Diseases. Early in her career, Dr. Le Goff spent 11 years in various leadership roles at Sanofi and Pfizer in the United States.

Dr. Le Goff is currently a Director of Acticor Biotech, of Longboard Pharmaceuticals and of EuroAPI. She also served on the Board of Directors of CFAO, a trading company that operates in Africa, for 6 years until December 2020. Dr. Le Goff earned a PhD in pharmaceutical sciences from Rene Descartes University in Paris and an MBA from Sorbonne University and INSEAD. She also holds qualifications from Northwestern University and the Hong Kong University of Science and Technology. She received the distinction of being named a Chevalier de la Légion d’Honneur in 2014. She holds a U.S. patent, and was recently recognized by Forbes Magazine as one of the women over the age of 50 who are changing the world.

On July 19, 2022 Avista Therapeutics, reported that which recently launched as a spinout of leading health system UPMC, aims to develop innovative gene therapies for rare ophthalmic conditions (Press release, Hoffmann-La Roche, JUL 19, 2022, View Source [SID1234616752]). The new company reported a partnership with Roche to develop novel AAV gene therapy vectors for the eyes.

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The partnership aims to apply Avista’s single-cell adeno-associated virus (AAV) engineering (scAAVengr) platform technology to develop intravitreal AAV capsids matching a capsid profile defined by Roche. Under the terms of the partnership, Roche has the right to evaluate and license novel capsids from Avista, and will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy programs using these novel capsids, which will be distinct from Avista’s internal pipeline.

"We are excited to enter into this collaboration with Roche, a global leader in health care," said Robert Lin, Ph.D., Chief Executive Officer of Avista Therapeutics. "This collaboration will complement our in-house pipeline and will accelerate the delivery of transformative therapies to patients."

Avista will receive an upfront payment of $7.5 million and, if successful, is eligible to receive additional payments during the research phase of the partnership, as well as clinical and sales milestone payments and royalties for resulting products with a total potential deal value that may exceed $1 billion.

Built on the research of leading experts in viral vector development and clinical ophthalmology, Avista was founded by Leah Byrne, Ph.D., Assistant Professor of Ophthalmology at the University of Pittsburgh School of Medicine, an expert in AAV vector generation, José-Alain Sahel, M.D., Chair of the Department of Ophthalmology at the University of Pittsburgh School of Medicine, who is known worldwide for his expertise in vision restoration techniques, and Paul Sieving, M.D., Ph.D., internationally recognized physician-scientist and former director of the National Eye Institute.

Avista’s computationally guided, in vivo scAAVengr platform leverages a high-throughput approach with built-in quantitative validation of novel cell-specific AAVs, enabling the rapid translation of transformative gene therapies to the clinic for diseases impacting people’s vision. The company will develop a proprietary pipeline built on a toolkit of AAV variants that can target gene delivery to individual retinal cell types.

"Traditional therapies for retinal dystrophies address only symptoms and complications, neglecting the underlying biology of the diseases, and while current vector technologies hold promise, they have been greatly limited in their ability to target key cell types across the retina," added Dr. Lin, who is also a vice president at UPMC Enterprises, the innovation, venture capital and commercialization arm of UPMC. "Avista was founded to solve this problem, and our innovative scAAVengr platform allows us to deliver gene therapy payloads through intravitreal injection to treat a full range of retinal diseases with reduced immunogenicity."

Avista received $10 million in seed funding and years of foundational support from UPMC Enterprises, which invests in translational science with the potential to radically transform health care.

"UPMC is thrilled to support the launch of Avista, a team with unmatched expertise in AAV technology and clinical ophthalmology who are addressing a diverse group of blinding disorders that have a profound impact on patients’ quality of life," said Jeanne Cunicelli, President of UPMC Enterprises. "We believe that Avista is uniquely positioned to address the high unmet medical need in inherited retinal diseases."

On July 19, 2022 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that it will report financial results for the quarter ended June 30, 2022, on Tuesday, August 2, 2022 after the close of the market, and provide a corporate update (Press release, Aptose Biosciences, JUL 19, 2022, View Source [SID1234616751]).

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Conference Call & Webcast:

*Please note the change in platform. Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a personal PIN, which are required to access the conference call. They also will have the option to take advantage of a new Call Me button and the system will automatically dial out to connect to the Q&A session.

The audio webcast can also be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2022 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On July 19, 2022 Novartis reported a solid second quarter (Press release, Novartis, JUL 19, 2022, View Source [SID1234616749]). Our six key in-market growth drivers with multi-billion sales potential (Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio) each grew at least double digits . The mid-stage pipeline remains on-track for 20+ potential significant pipeline assets with approval by 2026. Sandoz performance allows us to increase its guidance for the full-year and the strategic review is on track. Implementation of our streamlined organizational model is progressing well and is now expected to deliver approximately USD 1.5 billion in savings. We reconfirm our 2022 Group guidance and our confidence in delivering consistent growth and margin expansion."

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1 Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 47 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2 A table showing the Q2 2022 and H1 2022 key figures excluding Roche can be found on page 9 and a reconciliation of 2021 IFRS results and non-IFRS measures core results to exclude the impacts of the 2021 divestment of our Roche investment can be found on page 55 of the Condensed Interim Financial Report. 3 Please see detailed guidance assumptions on page 7.

Strategy Update
Novartis is a focused medicines company, with depth in five core therapeutic areas (Hematology, Solid Tumors, Immunology, Neuroscience and Cardiovascular), strength in technology platforms (Gene Therapy, Cell Therapy, Radioligand Therapy, Targeted Protein Degradation and xRNA), and a balanced geographic footprint. Our confidence to grow in the near to mid-term is driven by potential multi-billion-dollar sales from our key growth brands: Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio. To fuel further growth through 2030 and beyond, we have 20+ assets with significant sales potential that could be approved by 2026.
Novartis remains disciplined and shareholder focused in our capital allocation. We balance investing in our business, through organic investments and value-creating bolt-ons, with returning capital to shareholders via our growing annual dividend and share buybacks. Our previously announced up to USD 15 billion share buyback is ongoing, with USD 9.4 billion still to be executed.
In April, we announced a streamlined organizational model, designed to support innovation, growth and productivity, the implementation of which is progressing well. With the changes, Novartis now expects to deliver SG&A savings of approximately USD 1.5 billion, to be fully embedded by 2024. The savings will contribute to achieving mid to long-term IM core margins in the low 40’s and investing in our pipeline.
The strategic review of Sandoz is on track; we expect to provide an update, at the latest, by the end of 2022.
Novartis continues to make significant strides in building trust with society and consistently integrating access strategies into how we research, develop and deliver our medicines. We are committed to net zero emissions across our value chain by 2040. During the quarter, our MSCI ESG rating was increased to "AA", placing us in the top quartile of companies within the pharmaceutical industry. Our culture journey towards an inspired, curious and unbossed organization continues, in order to drive performance and competitiveness in the long-term.

Financials
Second quarter
Net sales were USD 12.8 billion (-1%, +5% cc) in the second quarter, driven by volume growth of 12 percentage points, price erosion of 4 percentage points and the negative impact from generic competition of 3 percentage points.
Operating income was USD 2.2 billion (-36%, -30% cc), mainly due to lower product divestment gains (USD 0.4 billion), higher impairments (USD 0.4 billion) and higher restructuring costs (USD 0.3 billion) primarily related to the implementation of the new organizational model.
Net income was USD 1.7 billion (-41%, -34% cc), mainly due to lower operating income. Excluding the impact of Roche income, net income declined -29% (cc). EPS was USD 0.77 (-40%, -33% cc). Excluding the impact of Roche income, EPS declined -27% (cc).
Core operating income was USD 4.3 billion (-2%, +5% cc), mainly driven by higher sales, partly offset by higher R&D and M&S investments and lower gross margin. Core operating income margin was 33.4% of net sales, decreasing by 0.1 percentage points (+0.1 percentage points cc).
Core net income was USD 3.4 billion (-8%, -1% cc), as growth in core operating income was more than offset by the loss of Roche core income. Excluding the impact of Roche core income, core net income grew +8% (cc). Core EPS was USD 1.56 (-6%, +1% cc), benefiting from lower weighted average number of shares outstanding. Excluding the impact of Roche core income, core EPS grew +10% (cc).
Free cash flow amounted to USD 3.3 billion (-22% USD), compared to USD 4.2 billion in the prior year quarter, mainly due to lower divestment proceeds and unfavorable changes in working capital.

Innovative Medicines net sales were USD 10.5 billion (-1%, +5% cc) with volume contributing 13 percentage points to growth. Sales growth was mainly driven by continued strong performance from Entresto, Kesimpta, Cosentyx, Kisqali and Zolgensma. Generic competition had a negative impact of 4 percentage points, mainly due to Afinitor/Votubia, Gilenya (ex-US), Gleevec/Glivec, Exjade, and Sandostatin. Pricing had a negative impact of 4 percentage points. Sales in the US were USD 3.9 billion (+6%) and in the rest of the world USD 6.5 billion (-5%, +5% cc).
Sandoz net sales were USD 2.3 billion (-3%, +5% cc), benefiting from a return towards normal business dynamics, with growth across all business franchises. Volume contributed 11 percentage points to growth and pricing had a negative impact of 6 percentage points. Sales in Europe grew +4% (cc), while sales in the US declined -1%. Global sales of Biopharmaceuticals grew to USD 528 million (+1%, +11% cc).
First half
Net sales were USD 25.3 billion (+0%, +5% cc) in the first half, driven by volume growth of 12 percentage points, price erosion of 4 percentage points and the negative impact from generic competition of 3 percentage points.
Operating income was USD 5.1 billion (-14%, -7% cc), mainly due to lower product divestment gains (USD 0.4 billion), unfavorable fair value adjustments on financial assets (USD 0.2 billion) and higher restructuring costs (USD 0.2 billion) primarily related to the implementation of the new organizational model.
Net income was USD 3.9 billion (-21%, -14% cc), mainly due to lower operating income. Excluding the impact of Roche income, net income declined -4% (cc). EPS was USD 1.77 (-20%, -12% cc). Excluding the impact of Roche income, EPS declined -3% (cc).
Core operating income was USD 8.4 billion (+1%, +7% cc), mainly driven by higher sales, partly offset by higher R&D and M&S investments. Core operating income margin was 33.0% of net sales, increasing by 0.3 percentage points (+0.6 percentage points cc).
Core net income was USD 6.7 billion (-6%, +0% cc), as growth in core operating income was offset by the loss of Roche core income. Excluding the impact of Roche core income, core net income grew +9% (cc). Core EPS was USD 3.02 (-5%, +2% cc), benefiting from lower weighted average number of shares outstanding. Excluding the impact of Roche core income, core EPS grew +11% (cc).
Free cash flow amounted to USD 4.2 billion (-28% USD), compared to USD 5.8 billion in the prior year period, mainly due to lower divestment proceeds, unfavorable changes in working capital, and the loss of Roche annual dividend (prior year USD 0.5 billion), partly offset by favorable hedging results.
Innovative Medicines net sales were USD 20.6 billion (0%, +5% cc) with volume contributing 12 percentage points to growth. Sales growth was mainly driven by continued strong performance from Entresto, Kesimpta, Cosentyx, Kisqali and Zolgensma. Generic competition had a negative impact of 3 percentage points, mainly due to Afinitor/Votubia, Gleevec/Glivec, Exjade, Gilenya (ex-US) and Exforge. Pricing had a negative impact of 4 percentage points. Sales in the US were USD 7.6 billion (+4%) and in the rest of the world USD 13.1 billion (-3%, +5% cc).
Sandoz net sales were USD 4.7 billion (-1%, +6% cc), benefiting from a lower prior year comparison, which was most notable for the cough and cold season, as business dynamics continued to return towards normal. Volume contributed 13 percentage points and pricing had a negative impact of 7 percentage points. Sales in Europe grew +7% (cc), while sales in the US declined -2%. Global sales of Biopharmaceuticals grew to USD 1.0 billion (+1%, +9% cc).

Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.
During the first half of 2022, Novartis repurchased a total of 61.7 million shares for USD 5.4 billion on the SIX Swiss Exchange second trading line under the up-to USD 15 billion share buyback announced in December 2021. In addition, 1.2 million shares (for an equity value of USD 0.1 billion) were repurchased from employees. In the same period, 10.8 million shares (for an equity value of USD 0.5 billion) were delivered as a result of options exercised and share deliveries related to participation plans of employees. Novartis aims to offset the dilutive impact from equity based participation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 52.1 million versus December 31, 2021. These treasury share transactions resulted in an equity decrease of USD 5.0 billion and a net cash outflow of USD 5.2 billion.
As of June 30, 2022, net debt increased to USD 9.5 billion compared to USD 0.9 billion at December 31, 2021. The increase was mainly due to the USD 7.5 billion annual dividend payment and net cash outflow for treasury share transactions of USD 5.2 billion, partially offset by USD 4.2 billion free cash flow during the first half of 2022.
As of Q2 2022, the long-term credit rating for the company is A1 with Moody’s Investors Service and AA- with S&P Global Ratings.

Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no Gilenya and no Sandostatin LAR generics enter in the US.
In June 2022, an appeals court held the Gilenya US dosing regimen patent invalid. Novartis plans to petition the appeals court for further review to uphold validity of the dosing regimen patent. There is no generic competition in the US at this time. In Q2, Gilenya US sales were USD 332 million, US sales have been steadily declining due to competitive pressures.

Foreign exchange impact
If mid-July exchange rates prevail for the remainder of 2022, the foreign exchange impact for the year would be negative 6 to negative 7 percentage points on net sales and negative 7 to negative 8 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

On July 19, 2022 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2022. "Our solid second quarter results across Johnson & Johnson reflect the strength and resilience of our Company’s market leadership in the midst of macroeconomic challenges," said Joaquin Duato, Chief Executive Officer (Press release, Johnson & Johnson, JUL 19, 2022, View Source [SID1234616748]). "I am continually energized by the focus and passion of my Johnson & Johnson colleagues and their dedication toward delivering transformative healthcare solutions to patients and consumers around the world."

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1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
Note: values may have been rounded

REGIONAL SALES RESULTS

1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: Values may have been rounded

SEGMENT SALES RESULTS

1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on operational changes
Note: Values may have been rounded

SECOND QUARTER 2022 SEGMENT COMMENTARY:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health

Consumer Health worldwide adjusted operational sales increased 2.9%*. Major contributors to growth include upper respiratory and analgesic products in the international market of our over-the-counter franchise as well as IMODIUM in digestive health products and NEUTROGENA in international Skin Health/Beauty.

Pharmaceutical

Pharmaceutical worldwide adjusted operational sales grew 12.4%*, driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases and IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer.

MedTech

MedTech worldwide adjusted operational sales grew 3.4%*, driven primarily by contact lenses and surgical vision products in our Vision franchise, and electrophysiology products in our Interventional Solutions business. Growth was partially offset by COVID-19 related mobility restrictions in certain regions.

NOTABLE NEW ANNOUCEMENTS IN THE QUARTER:

The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory Decisions

European Commission Grants Conditional Approval of CARVYKTI (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

(Press Release)

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma

(Press Release)

Janssen Receives Positive CHMP Opinion for IMBRUVICA (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL)

(Press Release)

Other

Johnson & Johnson Appoints Thibaut Mongon as CEO Designate of Planned New Consumer Health Company

(Press Release)

ETHICON Launches Next Generation ECHELON 3000 Stapler Designed for Exceptional Access and Control

(Press Release)

Johnson & Johnson Releases 2021 Health for Humanity Report Highlighting Performance on ESG Priorities and Progress Against Public Commitments

(Press Release)

New Data Show TREMFYA (guselkumab) Binds to Both Inflammatory Cells and Interleukin (IL)-23, Supporting a Hypothesis for a Differentiated Mechanism from Risankizumab

(Press Release)

Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)

FULL-YEAR 2022 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

($ in Billions, except EPS)

July 2022

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: April 2022 = $1.09 and July 2022 = $1.05 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:

Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.