On July 29, 2020 Boston Scientific Corporation (NYSE: BSX) reported sales of $2.003 billion during the second quarter of 2020 (Press release, Boston Scientific, JUL 29, 2020, View Source [SID1234562496]). This represents a decline of (23.9) percent on a reported basis, (23.1) percent on an operational1 basis and (28.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP loss of $147 million or $(0.11) per share (EPS), compared to GAAP earnings of $154 million or $0.11 per share a year ago, and achieved adjusted earnings per share of $0.08 for the period, compared to $0.39 a year ago.

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"We remain focused on the safety of our team, our customers and the patients they serve, and were pleased to see the business recovering over the course of the quarter," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "With a strong pipeline of differentiated products and an agile global team, we’ll continue to execute on our strategy and make prudent decisions to position us for success as deferred procedures resume."

Second quarter financial results and recent developments:

Reported a GAAP loss of $(0.11) per share. Achieved adjusted earnings per share of $0.08. The company did not provide second quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
Second quarter sales declined in each of our reportable segments4, compared to the prior year period:

MedSurg: (29.6) percent reported, (29.1) percent operational and (28.4) percent organic
Rhythm and Neuro: (33.2) percent reported, (32.7) percent operational and (33.4) percent organic
Cardiovascular: (18.7) percent reported, (17.6) percent operational and (25.3) percent organic

Second quarter regional5 sales declined, compared to the prior year period:

U.S.: (28.4) percent reported and operational
EMEA (Europe, Middle East and Africa): (27.2) percent reported and (25.6) percent operational
APAC (Asia-Pacific): (14.8) percent reported and (14.0) percent operational
Emerging Markets3: (19.7) percent reported and (14.6) percent operational

Received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device which is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation. This next-generation implant is the first LAAC device that can be fully recaptured, repositioned and redeployed in the left atrial appendage, with additional design features to enhance safety and performance while treating a wider range of patient anatomies than the previous WATCHMAN LAAC device.
Received FDA approval for the SYNERGY XD Bioabsorbable Polymer (BP) Drug-Eluting Stent (DES) System, the next-generation SYNERGY BP-DES platform with the only 48 mm length DES available in the U.S. and enhanced deliverability features to enable improved arterial navigation in percutaneous coronary intervention (PCI) cases. The system was recently launched in Japan following approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Received FDA 510(k) clearance and began limited market release for the LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope. The LUX-Dx ICM System can be programmed remotely and have settings adjusted without requiring patients to visit their physician’s office and is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians.
Received approval for the Eluvia Drug-Eluting Vascular Stent System from China’s Center for Medical Device Evaluation and will begin a limited market release by the end of the year. Also announced results of a sub-study of patients from the IMPERIAL trial who were treated with the Eluvia stent during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trials Livestream event. Data demonstrated the Eluvia stent offers durable and consistent results in complex and long lesions, with an average lesion length of 162.8 mm and that patients treated with the Eluvia stent had a 77.2% Kaplan-Meier primary patency rate, a 13.6% clinically-driven target lesion revascularization rate and no stent thrombosis, despite long, heavily calcified lesions.
Received CE Mark and began limited European release for the INTELLANAV STABLEPOINT Ablation Catheter enabled with DIRECTSENSE Technology. This first-of-its-kind catheter combines measures of mechanical contact, or contact force, with local impedance to provide insight into the cardiac tissue’s response to ablation.
Received Centers for Medicare & Medicaid Services (CMS) approval for a new transitional pass-through (TPT) payment category to describe single-use endoscopes, including the EXALT Model D Single-Use Duodenoscope, to facilitate Medicare beneficiary access to the advantages of new and innovative devices by allowing for adequate payment while cost data is collected, starting July 1, 2020. The EXALT duodenoscope is the world’s first and only single-use, flexible duodenoscope cleared by the U.S. Food and Drug Administration (FDA), which eliminates the risk of infection from inadequate scope reprocessing between procedures.
Presented positive findings from the largest reported clinical experience to date with the LOTUS Edge Aortic Valve System at TVT Connect. Data from a pre-specified interim analysis of the first 50 patients enrolled in the European RESPOND EDGE post-market registry demonstrated no reports of mortality, no repeat procedures for valve-related dysfunction or re-hospitalization for valve-related symptoms and excellent valve hemodynamics, the lowest PVL rates in this valve category and a reduced permanent pacemaker implantation rate in line with competitive valves in real-world experience.
Commenced enrollment of the FROZEN-AF investigational device exemption (IDE) clinical trial which will evaluate the safety and effectiveness of the POLARx Cryoablation System for the treatment of paroxysmal atrial fibrillation (AF), an intermittent form of AF which causes an irregular and often abnormally fast heart rate.
Announced at HRS 2020 Science final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System, the only FDA-approved implantable defibrillator without wires touching the heart, demonstrating high efficacy and safety of the device and a lower rate of inappropriate shock than many similar devices. Also presented as a late-breaking clinical trial at the virtual meeting were results from the investigator-sponsored PRAETORIAN trial confirming that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing.
Published a meta-analysis of 1,011 prostate cancer patients in The Journal of the American Medicine Association (JAMA) Network Open which found that placing SpaceOAR Hydrogel before radiation is an effective preventative strategy to reduce treatment-induced rectal complications. Each year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 men will undergo prostate radiotherapy. Recently, SpaceOAR surpassed 100,000 patients treated worldwide.
Announced The Lancet Neurology publication of the INTREPID study—a double-blind, randomized study evaluating the Vercise Deep Brain Stimulation (DBS) system for Parkinson’s disease. One-year results demonstrated a significant 51% improvement in motor symptoms (UDPRS III scores) compared to pre-surgery screening and six additional hours of ON time – or daily symptom control – over medication.
Launched a multi-year program to combat racism, inequity and injustice, including $3.5 million in philanthropic commitments, focused on five pillars: community, economic empowerment, education, healthcare disparities and government/legislative change.
Increased financial flexibility by completing a public offering of $1.7 billion aggregate principal amount of Senior Notes, as well as completing an approximately $2.0 billion public offering of common stock and mandatory convertible preferred stock, and using a portion of the proceeds of both offerings to repay borrowings under our revolving credit facility and a significant portion of our pre-payable bank debt.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, as well as the Q2 divestiture of our intrauterine health franchise.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition.

5. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On July 29, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported the pricing of an underwritten public offering of 52,173,913 shares of its common stock (Press release, Sunesis, JUL 29, 2020, View Source [SID1234562495]). The public offering price of each share of common stock is $0.23.

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Sunesis expects to receive gross proceeds of approximately $12 million from this offering, before deducting the underwriting discounts and estimated offering expenses. Sunesis has granted the underwriters a 30-day option to purchase up to an additional 7,826,086 shares of common stock to cover over-allotments, if any. This offering is expected to close on or about July 31, 2020, subject to customary closing conditions. Sunesis anticipates using the net proceeds from the proposed offering to fund ongoing development of PDK1 inhibitor SNS-510 and general corporate purposes.

Oppenheimer & Co. Inc. is acting as the sole book-running manager in this offering.

The securities described above are being offered by Sunesis pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), originally filed with the SEC on June 8, 2017 and which the SEC declared effective on November 21, 2017. A preliminary prospectus supplement related to the offering has been filed with the SEC and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary and final prospectus supplements and the accompanying prospectus relating to this offering, when available, may be obtained on the SEC’s website or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 29, 2020 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2020 and provided updated financial expectations for full-year 2020 (Press release, Alkermes, JUL 29, 2020, View Source [SID1234562494]). The company had previously withdrawn its 2020 financial expectations due to uncertainties regarding the impact of the COVID-19 pandemic on its business.

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"During the second quarter, we adapted in response to the changing conditions in a complex environment. As we enter the second half of 2020, we are focused on three strategic imperatives. The first is commercial execution, as we drive to maximize the opportunities for ARISTADA and VIVITROL and prepare for the potential launch of ALKS 3831. The second is aggressive development of our pipeline programs, focusing on high-value opportunities that we believe have the potential to address patient needs and drive significant value in the near- and long-term. ALKS 4230, our lead oncology candidate, is the most prominent of these opportunities. The third is efficient management of our operating structure, with a focus on rigorous expense management and careful prioritization of our investments," said Richard Pops, Chief Executive Officer of Alkermes.

"We distinguish ourselves from other biopharmaceutical companies through our efforts in serious mental illness and addiction — chronic, highly prevalent conditions that affect millions of people and represent some of the most challenging public health issues of our time. We have built our organization with purpose and invested in specialized commercial capabilities to navigate fragmented treatment systems as we help address the complex challenges that patients with these diseases face," continued Mr. Pops. "As the nation’s response to COVID-19 continues, it is critical that we work to mitigate the pandemic’s secondary impacts related to social isolation, economic hardship and anxiety. For many patients struggling with serious mental illness and addiction, the current environment has amplified the barriers to treatment that Alkermes has worked for many years to address. We believe it is our responsibility to help ensure that the treatment system continues to function for these patients."

Quarter Ended June 30, 2020 Financial Highlights

Total revenues for the quarter were $247.5 million, compared to $279.9 million for the same period in the prior year.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $29.4 million for the quarter, or a GAAP net loss per share of $0.19. This compared to GAAP net loss of $42.0 million, or a GAAP net loss per share of $0.27, for the same period in the prior year.

Non-GAAP net income was $8.9 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.06. This compared to non-GAAP net income of $13.7 million, or a non-GAAP basic and diluted earnings per share of $0.09, for the same period in the prior year.

Quarter Ended June 30, 2020 Financial Results

Revenues

Net sales of proprietary products were $130.4 million, compared to $136.6 million for the same period in the prior year.

Net sales of VIVITROL were $71.6 million, compared to $88.2 million for the same period in the prior year, representing a decrease of approximately 19%, driven primarily by a decline in new patient starts and more restricted access to healthcare providers that resulted from COVID-19-related disruptions.

Net sales of ARISTADA1 were $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21% driven primarily by increased breadth of the ARISTADA provider base and growth of the ARISTADA two-month dose.

Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to RISPERDAL CONSTA.

Costs and Expenses

Total operating expenses were $281.2 million, compared to $315.8 million for the same period in the prior year.

Research and Development (R&D) expenses were $94.2 million, compared to $104.4 million for the same period in the prior year.

Selling, General and Administrative (SG&A) expenses were $132.0 million, compared to $155.1 million for the same period in the prior year.

Balance Sheet

At June 30, 2020, Alkermes recorded cash, cash equivalents and total investments of $539.6 million, compared to $549.7 million at March 31, 2020. Cash on hand at June 30, 2020 significantly exceeded the company’s total debt outstanding of $276.1 million under its term loan, which matures in March 2023.

"Our second quarter results reflect solid execution across the business. The performance of the ARISTADA product family, together with disciplined management of expenses, partially offset the negative impact on VIVITROL net sales that resulted from COVID-19-related decreases in patient visits to healthcare providers and treatment centers. With increased visibility into the expected impact of COVID-19 on our commercial portfolio, today we are issuing financial expectations for 2020 that reflect current trends and underscore our commitment to driving non-GAAP profitability," commented James Frates, Chief Financial Officer of Alkermes. "Over the past five years, we have grown our topline while investing in the future growth drivers of our business. Directly as a result of those investments, we established VIVITROL as an important therapeutic option for patients with opioid and alcohol dependence; we secured FDA approvals for the ARISTADA product family; we developed ALKS 3831 and submitted a New Drug Application for schizophrenia and bipolar I disorder; we built commercial psychiatry capabilities that support the growth of ARISTADA and which are also fully leverageable for ALKS 3831; we successfully developed VUMERITY and entered into a commercial collaboration that will provide 100% gross margin royalty revenues from net sales; we advanced development of ALKS 4230 while retaining optionality for strategic collaboration; and, we acquired a platform of histone deacetylase (HDAC) inhibitors that we believe will provide compelling pipeline opportunities in

neurodegeneration and oncology. We are focused on executing our business strategy and believe these investments have positioned the business to drive long-term profitability and value creation."

Financial Expectations for 2020

The following financial expectations for 2020 reflect the anticipated net impacts of the COVID-19 pandemic on Alkermes’ operating and financial results. Alkermes anticipates that the negative impact of COVID-19 on VIVITROL net sales will be partially offset by a decrease in operating expenses, notably within R&D. The ranges provided are based on current trends and assume that treatment provider practices and patient flow will continue to normalize. Additional wide-spread COVID-19-related restrictions or resurgence of COVID-19 could negatively impact the company’s ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

Governance Update

"Over the past 12 months, we conducted extensive shareholder outreach and engaged with shareholders representing approximately 60% in value of our outstanding ordinary shares. The Board values the views of our shareholders and, after considering their feedback, is taking actions to further strengthen our business and corporate governance practices. The Board believes these actions will help to position the company for long-term growth as we execute on our strategy," said David Anstice, Lead Independent Director of the Alkermes Board of Directors (the Board).

The company announced today that it plans to take a series of actions as part of its commitment to corporate governance best practices and regular Board refreshment.

First, the Board will recommend that shareholders approve, at the company’s 2021 Annual General Meeting of Shareholders, an amendment to the company’s Articles of Association to declassify the Board. Currently, the Board has three classes of directors, with directors in each class elected to three-year terms. Once the Board is declassified, the directors will be combined into a single class elected annually.

Second, the Board has engaged a leading recruitment firm to identify independent director candidates whose experience and expertise offer valuable insights and strategic leadership at this stage in Alkermes’ evolution. As part of this process, the company expects certain of its longer-serving directors will retire from the Board. This Board refreshment process will continue and build on the efforts undertaken by the company in the fall of 2019 that led to the addition of two highly-qualified, independent directors, Dr. Richard Gaynor and Mr. Andy Wilson, to the Board.

Recent Events

Schizophrenia portfolio

In May 2020, presented new research from the company’s schizophrenia portfolio at the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting, including data from patient-reported evaluations relating to treatment with ALKS 3831 and satisfaction data relating to treatment with ARISTADA.

In July 2020, announced a new survey conducted by The Harris Poll for Alkermes, which explored the current use and future potential of telepsychiatry services during and after the COVID-19 pandemic.

ALKS 4230

In June 2020, presented positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis Oncology, Inc.’s investigational angiogenesis inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II.

Corporate citizenship

In June 2020, announced that 10 nonprofit organizations were awarded grants from the company’s COVID-19 Relief Fund, a special edition of the company’s signature Alkermes Inspiration Grants program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer.

In July 2020, published Alkermes’ latest Corporate Responsibility Report which outlines how the company integrates environmental, social and governance considerations into all aspects of its business. A copy of the report is available on the Responsibility section of Alkermes’ website.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020, to discuss these financial results, financial expectations, and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 5, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13707215.

On July 29, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required (Press release, Merck & Co, JUL 29, 2020, View Source [SID1234562493]). The FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a Phase 2 trial evaluating MK-6482 in patients with VHL-associated clear cell RCC, which were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Merck’s diverse and expansive oncology pipeline is focused on bringing forward innovative new treatments to patients in need and continues to show important progress," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "These designations for MK-6482 support the potential of targeting HIF-2α in certain patients with von Hippel-Lindau disease, who currently have limited treatment options and face an increased risk for benign tumors as well as several types of cancer, including renal cell carcinoma."

The FDA’s Breakthrough Therapy designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and that have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint. The FDA’s orphan drug designation is granted to medicines that are intended for the treatment, prevention or diagnosis of rare diseases that affect fewer than 200,000 people in the U.S.

About MK-6482

MK-6482 (formerly PT2977) is an investigational, novel, potent, selective, oral HIF-2α inhibitor that is currently being evaluated in a Phase 3 trial in advanced RCC (NCT04195750), a Phase 2 trial in VHL-associated RCC (NCT03401788), and a Phase 1/2 dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738). Proteins known as hypoxia-inducible factors, including HIF-2α, can accumulate in patients when VHL, a tumor-suppressor protein, is inactivated. The accumulation of HIF-2α can lead to the formation of both benign and malignant tumors. This inactivation of VHL has been observed in more than 90% of ccRCC tumors. Research into VHL biology that led to the discovery of HIF-2α was awarded the Nobel Prize in Physiology or Medicine in 2019.

About Von Hippel-Lindau Disease and Renal Cell Carcinoma

Von Hippel-Lindau disease is a rare genetic disease that affects one in 36,000 people (200,000 cases worldwide and 10,000 cases in the U.S. alone). Patients with VHL disease are at risk for benign blood vessel tumors as well as several cancers, including RCC. As many as 60% of people with VHL disease develop RCC, which is a leading cause of death for patients with VHL disease.

Renal cell carcinoma is by far the most common type of kidney cancer; about nine of 10 kidney cancers are RCCs, and about seven of 10 RCCs are clear cell. Worldwide, it is estimated there were about 403,000 cases of kidney cancer diagnosed and about 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On July 29, 2020 United Therapeutics Corporation (Nasdaq: UTHR) reported its financial results for the quarter ended June 30, 2020 (Press release, United Therapeutics, JUL 29, 2020, View Source [SID1234562492]).

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"I am pleased with our performance during the second quarter, and feel that we are well positioned for a return to revenue growth in the near term as our prescriptions and new patient starts have been approaching pre-pandemic levels," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "Orenitram continues to grow following our FREEDOM-EV label update, and we believe the INCREASE study results will lead to significant Tyvaso growth. In addition, our new subcutaneous Remunity Pump and intravenous Implantable System for Remodulin products, while delayed, are nevertheless forthcoming in the near term as manufacturing and regulatory requests get resolved."

The reduction in Remodulin revenue was driven primarily by a reduction in quantities sold in Europe, which we believe resulted from generic competition and the impact of COVID-19, and to a lesser extent, by a reduction in quantities sold in the United States, which we believe resulted from COVID-19 related reductions in new patient prescriptions and new patient starts due to access restrictions at physician offices. The growth in Orenitram revenue resulted primarily from an increase in quantities sold, as the number of patients being treated with Orenitram has grown following the update to Orenitram’s labeling to reflect the FREEDOM-EV clinical trial results. The decrease in Adcirca revenues was driven by continued erosion of market share due to generic competition.

The increase in share-based compensation expense for the three months ended June 30, 2020, as compared to the same period in 2019, was primarily due to an increase in STAP expense driven by a 28 percent increase in our stock price for the three months ended June 30, 2020, as compared to a 33 percent decrease in our stock price for the same period in 2019.
Other (Expense) Income, Net. The change in other (expense) income, net for the three months ended June 30, 2020, as compared to the same period in 2019, was primarily due to net unrealized and realized gains and losses on equity securities.

Non-GAAP Earnings
Non-GAAP earnings is defined as net income, adjusted for: (i) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards, and our employee stock purchase plan); (ii) net unrealized and realized losses (gains) on equity securities; (iii) impairment charges; (iv) license-related fees; and (v) tax impact on non-GAAP earnings adjustments.

Recorded within operating expenses on our consolidated statements of operations.

Recorded within "other (expense) income, net" on our consolidated statements of operations.

Recorded within research and development on our consolidated statements of operations.
NEW PRODUCT COMMERCIALIZATION UPDATE
In our near-term time horizon, we plan to launch Tyvaso for a new indication, and to launch three new products for pulmonary arterial hypertension (PAH): the Remunity Pump, the Trevyent system, and the Implantable System for Remodulin.
Tyvaso in pulmonary hypertension due to interstitial lung disease (PH-ILD) — INCREASE. On February 24, 2020, we reported that the INCREASE study of Tyvaso in patients with PH-ILD met its primary endpoint of demonstrating improvement in six-minute walk distance (6MWD). Tyvaso also showed benefits across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Significant improvements were also observed in each of the study’s secondary endpoints, including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events.
We presented these and other highlights of the INCREASE data at a recent virtual session of the American Thoracic Society entitled "Inhaled Treprostinil in Interstitial Lung Disease-Associated Pulmonary Hypertension: The INCREASE Study." We expect to make the full results of the study available through upcoming journal publications. In addition, we recently submitted the INCREASE study results to the U.S. Food and Drug Administration (FDA) in support of an efficacy supplement to the Tyvaso new drug application (sNDA), which we expect to result in revised labeling reflecting the outcome of the INCREASE study.

Remunity Pump for Remodulin. We commenced launch activities for the Remunity Pump for Remodulin, including shipping training devices to specialty pharmacies and certain health care practitioners, and entering into agreements with specialty pharmacies to purchase Remunity Pumps and accessories and to pre-fill the Remunity cartridges exclusively with Remodulin. We also confirmed with the relevant Centers for Medicare & Medicaid Services Pricing, Data Analysis, and Coding Contractor that the Remunity Pump will be treated as durable medical equipment under the Medicare Part B Durable Medical Equipment program, and will share the same billing codes and billing guidance as existing subcutaneous pumps currently used with Remodulin. We started working with large PAH medical centers to identify patient candidates for the Remunity Pump, and have been training staff at these centers on how to use the product. However, the timing of our ability to commence commercial sales has been delayed due to pandemic-related issues impacting the ability of our partner, DEKA Research & Development Corp. (DEKA), to secure certain components and raw materials necessary to manufacture a continuous supply of pumps, pump disposables, and pump controllers. We are working closely with DEKA to build safety stock of these components and raw materials to a level that would allow us to withstand a significant supplier disruption without adverse impact to our patient base. We implemented this strategy due to the increasing COVID-19 infection rates observed in the United States during the second quarter of 2020, as many of the Remunity Pump component suppliers are located domestically. We are working to commence commercial sales of the Remunity Pump in the near-term, but we cannot predict the precise timing due to the factors described above, as well as the potential for additional pandemic-related constraints that physicians and patients may experience.
Trevyent. We submitted a 505(b)(1) new drug application (NDA) to the FDA for our Trevyent disposable treprostinil pump system in June 2019. In April 2020, the FDA issued a complete response letter (CRL) related to our NDA indicating that some of the deficiencies previously raised by the FDA had not yet been addressed to its satisfaction. We have one year from the date of the CRL to resubmit our NDA to the FDA, which is expected to trigger a six-month review period by the FDA. We are preparing our NDA resubmission, which we expect to file in 2021.
Implantable System for Remodulin (ISR). Developed in collaboration with Medtronic, Inc. (Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017. However, our ability to launch the product is subject to Medtronic satisfying various conditions to its PMA approval. Medtronic continues to work toward satisfying these conditions, but in December 2019, due to FDA communications, Medtronic informed us that these conditions will not be satisfied in 2020. As such we expect a delay in the ISR launch until 2021.
RESEARCH AND DEVELOPMENT UPDATE
Our clinical studies remain open, and enrollment of new patients has resumed at select study sites for certain studies. Most of our ongoing clinical studies paused enrollment during the first quarter of 2020 due to the pandemic, but patients already enrolled in studies continue to receive the study drug and complete necessary clinical evaluations as appropriate.
The following studies have since re-opened enrollment at select sites:

the BREEZE and pivotal pharmacokinetics studies of Treprostinil Technosphere;

the ADVANCE OUTCOMES study of ralinepag;

the SAPPHIRE study of Aurora-GT;

our phase I study of Unexisome for bronchopulmonary dysplasia; and
•our phase I study of OreniPro.
We have also recommenced startup activities for the ADVANCE CAPACITY study of ralinepag. While enrollment of the PERFECT study of Tyvaso in pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) remains paused, we are continuing new clinical site startup activities for this study.
Although we re-opened enrollment of certain studies at a limited number of clinical trial sites, it is difficult to predict when we will be able to reopen enrollment at additional sites for these studies, and whether we will experience further disruptions as the pandemic unfolds. In addition, it is unclear what impact the pandemic may have on the timing of future studies, such as TETON. As such, we expect that completion and data readouts for several of our ongoing and planned studies will be delayed, but we do not currently expect delays of our near-, medium-, and long-term windows for product launch plans. To mitigate potential delays, we are expanding our efforts to enter into contracts with additional clinical study sites and complete other site activation activities for certain studies where practicable so that we may rapidly resume enrollment of our clinical studies at the appropriate time.

Treprostinil Technosphere dry powder inhaler — BREEZE. The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind. The primary endpoint of the study is the number of subjects with treatment-emergent adverse events after three weeks of treatment with the DPI. In March 2020, we commenced a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. We expect results of these two studies, combined with long-term stability studies of the DPI product, will form the basis of a 505(b)(1) NDA to the FDA.
Unituxin in relapsed/refractory neuroblastoma — ANBL1221. We are pursuing an indication expansion for Unituxin for the treatment of pediatric patients with relapsed or refractory neuroblastoma based on the results of the Children’s Oncology Group’s ANBL1221 study (NCT01767194). We met with the FDA in April of this year to discuss the content needed to support a supplemental biologics license application (BLA). We are working with Children’s Oncology Group to secure additional information ahead of a potential supplemental BLA.
Tyvaso in PH-COPD — PERFECT. The PERFECT study (NCT03496623) seeks to evaluate Tyvaso in patients with PH-COPD. In a 30-week crossover study, 136 subjects will be randomized between inhaled treprostinil and placebo for a 26-week treatment period. The primary endpoint of the study is the change in 6MWD from baseline to week 12 on active treatment compared to placebo. A contingent design for the study allows for the evaluation of 314 patients in two parallel groups.
Tyvaso in patients with chronic fibrosing interstitial lung disease (CFILD) — TETON. We are commencing a new phase III registration study called TETON, which is a randomized, double-blind, placebo-controlled, 24-week, phase III study of Tyvaso in subjects with CFILD (which includes patients with idiopathic interstitial pneumonias, chronic hypersensitivity pneumonitis, and environmental/occupational lung disease). Subjects will be randomized in a 1:1 ratio to receive inhaled treprostinil or placebo. The primary endpoint of this study is planned to be the change from baseline to week 24 in absolute forced vital capacity (FVC). This study was prompted by data from the INCREASE study, which demonstrated improvements in parameters of lung function in pulmonary hypertension patients with fibrotic lung disease (FVC and reduced exacerbations of underlying lung disease).
Ralinepag phase III development program — ADVANCE CAPACITY and ADVANCE OUTCOMES. We have two ongoing phase III clinical studies to support the potential registration of oral ralinepag for PAH.

ADVANCE CAPACITY. The phase III ADVANCE CAPACITY study (NCT04084678) seeks to evaluate 193 subjects with PAH, randomized between oral ralinepag and placebo at a 2:1 ratio, along with PAH background therapy, for 28 weeks. The primary endpoint of the study is the change from baseline to week 28 in peak oxygen consumption assessed by cardiopulmonary exercise testing.

ADVANCE OUTCOMES. The phase III ADVANCE OUTCOMES study (NCT03626688) seeks to evaluate approximately 700 PAH patients, randomized 1:1 between oral ralinepag and placebo along with background therapy. The primary endpoint is the time from randomization to the first adjudicated protocol-defined clinical worsening event.
Autologous cell therapy for PAH — SAPPHIRE. Conducted by our Canadian affiliate Northern Therapeutics, Inc., the phase II SAPPHIRE study seeks to evaluate the use of autologous endothelial progenitor cells (EPCs) genetically engineered to express endothelial nitric oxide synthase in patients with PAH taking conventional PAH treatments. The study seeks to enroll 45 PAH patients in one of three arms: (i) placebo for six months followed by autologous EPCs for six months; (ii) autologous EPCs for six months followed by placebo for six months; and (iii) autologous EPCs for 12 months. The primary endpoint is the change in 6MWD from baseline to month six.
INDUCEMENT RESTRICTED STOCK UNITS
On July 24, 2020, we granted a total of 916 restricted stock units under our 2019 Inducement Stock Incentive Plan to three newly hired employees. These restricted stock units vest in three equal installments on July 31, 2021, 2022, and 2023, assuming continued employment on such dates, and are subject to the standard terms and conditions we filed with the SEC as Exhibit 10.2 to our Current Report on Form 8-K on March 1, 2019. We provide this information in accordance with Nasdaq Listing Rule 5635(c)(4).

CONFERENCE CALL
We will host a teleconference on Wednesday, July 29, 2020, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (866) 209-9943 in the United States, with international callers dialing +1 (825) 312-2282. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing (800) 585-8367 in the United States, with international callers dialing +1 (416) 621-4642, and using access code: 2886748.