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Miravo Healthcare™ Announces Second Quarter 2021 Results

On August 9, 2021 Nuvo Pharmaceuticals Inc. (TSX: MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2021 (Press release, Nuvo Pharmaceuticals, AUG 9, 2021, View Source [SID1234586139]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and six months ended June 30, 2021, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments

Three months ended June 30, 2021 include the following:

Adjusted total revenue(1) was $19.9 million, an increase of 11% compared to $18.0 million for the three months ended June 30, 2020.
Adjusted EBITDA(1) was $7.4 million, a decrease of 3% compared to $7.6 million for the three months ended June 30, 2020.
Revenue related to Blexten and Cambia was $9.2 million, an increase of 46% compared to revenue of $6.3 million for the three months ended June 30, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 26% and 17% respectively compared to the three months ended June 30, 2020.
The Company repaid $3.0 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at June 30, 2021, cash and cash equivalents were $27.3 million.
Six months ended June 30, 2021 include the following:

Adjusted total revenue(1) was $34.5 million, a decrease of 7% compared to $37.0 million for the six months ended June 30, 2020.
Adjusted EBITDA(1) was $11.7 million, a decrease of 25% compared to $15.6 million for the six months ended June 30, 2020.
Revenue related to Blexten and Cambia was $14.8 million, an increase of 21% compared to revenue of $12.2 million for the six months ended June 30, 2020. Canadian prescriptions of Blexten and Cambia increased by 25% and 13% respectively compared to the six months ended June 30, 2020.
The Company repaid $6.6 million (US$5.4 million) of the Amortization Loan to Deerfield.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

In July 2021, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare (Miravo Ireland) entered into an exclusive license and supply agreement with SK Chemicals Co., Ltd. (SK Chemicals) for the exclusive right to commercialize Suvexx in the Republic of South Korea. Miravo Ireland will receive up to €1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in South Korea and revenue pursuant to the supply of product.
In May 2021, the Company announced the appointment of Mary Ritchie to its Board of Directors. Ms. Ritchie is the President and Chief Executive Officer of Richford Holdings Ltd., an accounting and investment advisory services firm based in Edmonton, Alberta. Ms. Ritchie has over 30 years of experience in both the public, private and not-for-profit sectors and is a Fellow of CPA Alberta. She is a member of the board of directors and audit committees of Alaris Royalty Corp. (TSX) and EnWave Corporation (TSXV). She has been a past director on a number of boards, including the Canada Pension Plan Investment Board, Industrial Alliance Insurance, Financial Services Inc. (TSX), iA Financial Corporation Inc. (TSX) and IPL Plastics Inc. (TSX) and a past member of the RBC Global Asset Management’s independent oversight committee.
In April 2021, the Company filed and obtained a receipt for a final base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada (the Prospectus). The Company has filed the Prospectus to maintain financial flexibility and to have the ability to offer the securities on an accelerated basis pursuant to the filing of prospectus supplements. The Prospectus is valid for a 25-month period, during which time the Company may offer and issue, from time-to-time, common shares, preferred shares, debt securities, warrants and subscription receipts, or any combination thereof, having an aggregate offering value of up to $40 million.
"Our key promoted brands, Blexten and Cambia, continued their solid performance and demonstrated year-over-year gains in prescription and revenue growth. New Blexten prescriptions now represent 1 in 4 new antihistamine prescriptions nationally, and 1 in 3 new antihistamine prescriptions in Ontario, Alberta, and British Columbia. Our recently launched Suvexx and NeoVisc brands are performing according to plan and are steadily growing market share," said Jesse Ledger, Miravo’s President & CEO. "Our international business also continues to expand with our recently announced Suvexx licensing agreement for South Korea. This represents our first Suvexx license partner for Asia and, once approved, will introduce Suvexx as a treatment option in a rapidly growing acute migraine market. This transaction is another example of our team executing on our business development objectives."

Second Quarter 2021 Financial Results
Adjusted total revenue was $19.9 million and $34.5 million for the three and six months ended June 30, 2021 compared to $18.0 million and $37.0 million for the three and six months ended June 30, 2020. The $1.9 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $4.3 million in the Commercial Business segment and an increase of $0.7 million of revenue from the Production and Service Business segment, slightly offset by a decrease of $3.1 million of revenue in the Licensing and Royalty Business segment. Adjusted total revenue attributable to the Commercial Business segment increased during the current quarter due to an increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), as well as an increase in sales of the Company’s mature products. The Production and Service Business segment adjusted total revenue increased as a result of an increase in the Company’s Pennsaid product sales, slightly offset by the strengthening of the Canadian dollar against the U.S. dollar, which decreased the value of U.S. denominated sales compared to the three months ended June 30, 2020. Adjusted total revenue decrease in the Licensing and Royalty Business segment as a result of a decrease in royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020, as well as a decrease in amounts billed to customers for existing contract assets. In the comparative quarter, the Company received a $2.4 million (US$1.8 million) milestone from Takeda Pharmaceutical Co., Ltd. related to the use of its Yosprala intellectual property in Japan.

Adjusted EBITDA was $7.4 million and $11.7 million for the three and six months ended June 30, 2021 compared to $7.6 million and $15.6 million for the three and six months ended June 30, 2020. During the three months ended June 30, 2021, increases in gross profit from the Company’s Commercial Business and Production and Service Business segments was more than offset by an increase in general and administrative expenses, as well as a decrease in the contribution from the License and Royalty Business segment due to a decline in the U.S. Vimovo royalty and a decrease in amounts billed to customers for existing contract assets.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue and adjusted EBITDA) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, August 9, 2021) at 11:00 a.m. ET. To participate in the conference call, please dial 416 764 8688 or 1 888 390 0546. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 16, 2021 by calling 416 764 8677 or 1 888 390 0541 / replay passcode: 457561#.

A live audio webcast of the conference call will be available through www.miravohealthcare.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

Herantis Invitation to 1H 2021 Financial Report Live Call on August 26, 2021

On August 9, 2021 Herantis Pharma Plc ("Herantis or the Company"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, reported that the company will report its half yearly financial report for the period January 1 – June 30, 2021 on Thursday, August 26th, 2021 at 9:00 EEST / 8:00 CEST (Press release, Herantis Pharma, AUG 9, 2021, View Source;2021,c3393805 [SID1234586138]). Investors, analysts and media are invited to a webcasted live call on the same day at 10:30 EEST / 9:30 CEST.To register for Herantis’ 1H 2021 Financial Report live call:Register Here: Herantis’ 1H 2021 Financial Report Live Call

Webinar ID: 235-655-763

Questions can be submitted throughout the webcast event.

Following the webcast of the live call, a recording will be available on Herantis Pharma’s website (www.herantis.com).

Eagle Pharmaceuticals Announces Licensing Agreement with AOP Orphan for U.S. Commercial Rights to Landiolol, a Beta-1 Adrenergic Blocker

On August 9, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that it has entered into a licensing agreement with AOP Orphan Pharmaceuticals GmbH ("AOP Orphan"), a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to its product, Landiolol in the United States (Press release, Eagle Pharmaceuticals, AUG 9, 2021, View Source [SID1234586137]). Landiolol, a leading hospital emergency use product, is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. The Company will support the submission of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia ("SVT"), including atrial fibrillation and atrial flutter.

Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Orphan that has a selective effect on heart rate over cardiac contractility. Landiolol is available in two forms (20 mg/2ml concentrate, 300 mg powder) and is designed for use in emergency, cardiac critical care, operating room, and intensive care settings. It is registered in several European countries for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. The drug uses a proprietary dosing algorithm to facilitate the administration.

Under the terms of the agreement, Eagle will facilitate the U.S. regulatory pathway for the approval of Landiolol. In addition, Eagle will be responsible for the U.S. commercialization of the product upon approval. Landiolol, which has not previously been marketed in the U.S., is covered by several patents, and the Company anticipates five years of new chemical entity ("NCE") exclusivity.

Landiolol is already commercially available in Japan (Onoact) and several European markets as RAPIBLOC. A review of multiple clinical studies suggests that Landiolol is a useful option for the rapid short-term control of tachyarrhythmias (Syed YY. Landiolol: A Review in Tachyarrhythmias. Drugs. 2018 Mar;78(3):377-388. doi: 10.1007/s40265-018-0883-9. PMID: 29470800.). A Type C meeting was held with FDA in July 2020, at which time AOP Orphan proposed a submission strategy in which it would provide summaries of pre-existing safety and efficacy data and a meta-analysis of published randomized controlled trials. FDA tentatively agreed with this methodological approach and deemed data sets adequate to support a proposed NDA.

"This is an exciting near-term opportunity for Eagle, with the potential to file an NDA in the first quarter of next year. The clinical advantages of Landiolol are well recognized within the medical community, and we look forward to advancing this asset for FDA approval in the United States. Our deep understanding of the U.S. regulatory landscape, along with our established research and development infrastructure, will be valuable in accelerating the program. Once approved, we plan to leverage our current sales force and relationships in the critical care setting to promote the product. There is broad potential to expand the portfolio of future indications for Landiolol’s use," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"With this license agreement, we are solidifying our hospital and critical care product portfolio, as we look to capitalize on multiple near- and longer-term opportunities. As we have stated, executing on our growth strategy for Eagle beyond 2021 has been a priority. With the anticipated launch of vasopressin, the February 2022 launch of PEMFEXY, the recent launch of bendamustine in Japan, our current pipeline, and now the future potential Landiolol launch, we believe we have a firm foundation for sustained future growth," concluded Tarriff.

"The step into the American market forms the basis for further expansion of AOP Orphan. I am convinced that with an experienced partner like Eagle, we will succeed in making Landiolol available to patients in the U.S. as well," stated Georg Fischer, Chief Executive Officer of AOP Orphan.

The management of rapid heart rate (tachycardia) in critically ill patients can be quite complicated regardless of the underlying cause, which may include shock, arrhythmias, heart failure, and the postoperative setting. Beta blockers, also known as beta-adrenergic blocking agents, are a class of drugs that works by blocking the neurotransmitters norepinephrine and epinephrine from binding to receptors. These neurotransmitters contribute to the development of tachycardia. The β-1 receptor beta blockers are used frequently in critical care settings to manage tachycardia; however, the available β-1 beta blockers in the U.S. also can have the unwanted effects of decreasing the contractility, or muscle strength, of the heart, and of lowering blood pressure.

Landiolol has the potential to become a cornerstone therapy in the management of these patients. It is ultra short acting, with a rapid on and off effect that allows clinicians to balance heart rate control and blood pressure more precisely. In addition, it predominantly affects heart rate without much effect on cardiac contractility and blood pressure. The Company believes that clinicians will welcome Landiolol as a key therapeutic tool for the more precise management of tachycardia in the critical care setting.

There are additional clinical settings for which Landiolol has the potential to improve patient management. Enrollment is under way in Europe for a trial of Landiolol in patients with tachycardia and septic shock, and importantly, the product is also being studied in a pediatric population, for whom no beta-blocker drug products are approved in the U.S. for ventricular rate control. The U.S. FDA has tentatively agreed that this study could form the basis for initial pediatric study plan ("iPSP") for a future submission to FDA.

"We believe that we can expedite and prepare a compelling submission for approval of this important cardioprotective therapeutic," stated Judith Ng-Cashin, MD, Chief Medical Officer of Eagle Pharmaceuticals

Terms of the Agreement

The agreement is subject to regulatory clearance. Under the terms of the agreement, Eagle will make an upfront payment of $5 million, followed by additional payments upon regulatory approval(s) and based upon commercial sales. The agreement is subject to regulatory clearance.

Molecular Partners to Regain Global Rights to Abicipar

On August 9, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported the receipt of notification from its partner, AbbVie Inc., regarding its termination of the license and collaboration agreement for the investigational drug abicipar pegol for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME) (Press release, Molecular Partners, AUG 9, 2021, View Source [SID1234586136]). As such, Molecular Partners will regain the development and commercial rights of abicipar on a worldwide basis.

"There remains a significant unmet medical need for patients living with nAMD and DME, and we remain confident in abicipar’s potential to offer these patients a differentiated treatment option over existing therapies," said Patrick Amstutz, Chief Executive Officer of Molecular Partners. "Our focus for this program will be determining the best path to value creation within the context of our expansive portfolio of antiviral and immuno-oncology therapies in development."

Molecular Partners will form a special committee to evaluate the program and determine appropriate next steps. In addition, Molecular Partners and AbbVie will continue their ongoing discovery alliance, in which AbbVie will continue to evaluate additional DARPin candidates for ophthalmic indications. The return of the abicipar program is not expected to impact Molecular Partners’ financial outlook for 2021 or previously issued guidance.

Abicipar is a long-acting anti-VEGF DARPin molecule which was invented by Molecular Partners and initially licensed to Allergan in 2011. The program has been through two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.

With the acquisition of Allergan by AbbVie, the rights to abicipar were transferred to AbbVie. In June 2020, AbbVie received a Complete Response Letter to the Biologics License Application for abicipar pegol, indicating that the rate of intraocular inflammation observed following administration of Abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of nAMD (AMD), and that additional work would be required to demonstrate a lower rate of ocular inflammation than what was previously seen in the Phase 3 studies.

Biohaven Reports Second Quarter 2021 Financial Results And Recent Business Developments

On August 9, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases including rare disorders, reported financial results for the second quarter ended June 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, Biohaven Pharmaceutical, AUG 9, 2021, View Source [SID1234586135]).

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Once again, the Biohaven team has outperformed business expectations for our CGRP receptor antagonist platform. Demand for NURTEC ODT is strong and our differentiated product is changing the paradigm by which migraine is treated. We are extremely proud of the success of our platform over the quarter, unlocking a sizable opportunity through the landmark approval of NURTEC ODT for both the acute and preventive treatment of migraine, while simultaneously bolstering innovation, and advancing clinical programs outside of our CGRP receptor antagonist franchise."

Dr. Coric continued, "We believe NURTEC ODT will continue to drive impressive revenue growth, but the true value is in the improved quality of life for those individuals who now have a one-stop solution for acute and preventive treatment of migraine. We are excited to pursue the science of CGRP antagonism with our broad platform of CGRP assets in pain adjacencies and non-migraine indications that we believe are driven by neuroimmune/neuroinflammatory interactions. The life-cycle management studies of NURTEC ODT and our other clinical CGRP-targeting assets including intranasal zavegepant, oral zavegepant, and BHV-3100 will pursue multiple indications with the goal of growing an industry leading CGRP franchise."

Second Quarter and Recent Business Highlights

Continued strong uptake of NURTEC ODT –During the second quarter of 2021, the Company saw significant net revenue growth, more than doubling over the first quarter of 2021, driven by improvement in both net price realization and volume. We believe there continues to be a significant market opportunity for oral CGRP targeting agents ahead, with a potential $4-5 billion annual market in the U.S. alone for the acute treatment of migraine. We will continue to invest in NURTEC’s long term success, driving its growth outside of the U.S. and continuing to expand commercial payer coverage. Despite the industry-wide commercial challenges throughout the pandemic, NURTEC ODT has now achieved over 875,000 prescriptions and over 44,000 unique prescribers to date and continues to exceed revenue expectations.

FDA Approves NURTEC ODT (rimegepant) for Preventive Treatment of Migraine – In May, the Company announced that the FDA approved NURTEC ODT for the preventive treatment of episodic migraine. This milestone approval makes NURTEC ODT the first and only medication approved to both treat and prevent migraine attacks, expanding the product label to include the use of NURTEC ODT 75 mg up to 18 doses per month. In the pivotal Phase 3 clinical trial, NURTEC rapidly and effectively prevented migraine, reducing migraine days by 30% after just 1 week of every other day treatment; by 3 months of treatment, approximately half of patients experienced at least a 50% reduction in moderate-to-severe migraine days.

United States Patent and Trademark Office awards ODT drug product patent for NURTEC ODT – In July, the Company received notice that the United States Patent and Trademark Office (USPTO) has awarded a patent directed to our drug product, NURTEC ODT (rimegepant), as well as other CGRP inhibitors, in an ODT form. This patent will expire in March 2039, not including patent term adjustment or any potential patent term extension. The patent is also pending in major market countries throughout the world including countries in Europe, Japan and China. This issuance of this patent extends the Company’s intellectual property protection for our CGRP platform until 2039.

Biohaven and Sosei Heptares collaboration initiates Phase 1 trial with novel small-molecule CGRP antagonist – In June, Biohaven and the Sosei Group Corporation dosed the first patient with BHV-3100 in a Phase 1 clinical study. BHV-3100 is a novel, small molecule CGRP receptor antagonist discovered by Sosei Heptares, which has demonstrated promising and differentiated properties to target CGRP-mediated disorders in preclinical development. The trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of a single ascending dose and multiple ascending doses of subcutaneous BHV-3100. The trial aims to enroll 88 subjects at a single center in the UK and is expected to complete in 2022.

Kishen Mehta appointed to Board of Directors – In June, Mr. Kishen Mehta joined Biohaven’s board. Mr. Mehta has approximately 15 years of experience in the financial industry and is currently a Portfolio Manager at Suvretta Capital Management, LLC, responsible for its healthcare-focused investment strategy, Averill, which attempts to identify companies that are disruptive to the healthcare industry. Previously, Mr. Mehta served as a strategic advisor to Biohaven Pharmaceuticals, where he advised the company on various business development, capital structure, and communication strategies. Mr. Mehta also had roles as a portfolio manager at Surveyor Capital, a Citadel LLC strategy, where he managed a portfolio focused on global small, mid, and large-capitalization biotechnology, pharmaceutical, specialty pharmaceutical, medical device, and healthcare services companies. Prior to Surveyor, Mr. Mehta was an analyst at Adage Capital where he evaluated and participated in numerous mezzanine and pre-IPO private healthcare investments. Mr. Mehta started his career as a mergers and acquisitions analyst at Evercore Partners, where he focused on life sciences.

George Clark, CPA appointed VP, Chief Accounting Officer – In August, the Company appointed Mr. George Clark as its Vice President, Chief Accounting Officer. Mr. Clark has been with Biohaven since 2018 and serving as Vice President of Finance. Prior to joining Biohaven, Mr. Clark held roles with KPMG, LLP as a Senior Audit Manager; The Hartford Financial Services Group, Inc. in external reporting and investment accounting; and began his career at PricewaterhouseCoopers, LLP. Mr. Clark is a graduate of the University of Connecticut where he earned Bachelor and Master of Science degrees in Accounting and is a Certified Public Accountant.

Upcoming Milestones:
Biohaven is continuing to support the launch of NURTEC ODT for the acute and preventive treatment of migraine, as well as develop our product candidates through clinical and preclinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones with its CGRP receptor antagonists, glutamate modulators, and myeloperoxidase inhibitors in the coming quarters.

Biohaven expects to:

Continue commercialization of NURTEC ODT for the dual indications of the acute and preventive treatment of migraine and advance regulatory efforts outside the U.S.
Report topline of intranasal zavegepant in the acute treatment of migraine in the second half of 2021, followed by filing by year end if positive results are achieved.
Report topline of verdiperstat for the treatment of MSA in the third quarter of 2021.
Complete enrollment of verdiperstat for the treatment of ALS in the fourth quarter of 2021.
Report topline of troriluzole in Spinocerebellar Ataxia in the first half of 2022.
Report topline of troriluzole in OCD in the second half of 2022.
Second Quarter Financial Results

Product Revenues, Net: Net product revenue was $92.9 million for the three months ended June 30, 2021, compared to $9.7 million for the three months ended June 30, 2020. The increase of $83.2 million in net product revenues is due to both increased NURTEC ODT sales volume and improvements in net price realization due to decreases in sales allowances during the three months ended June 30, 2021, compared to the three months ended June 30, 2020. The Company began selling NURTEC ODT in March 2020. Sales allowances and accruals mostly consisted of patient affordability programs, distribution fees and rebates.

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $77.4 million for the three months ended June 30, 2021, compared to $42.4 million for the three months ended June 30, 2020. The increase of $35.0 million was primarily due to an increase in both late-stage product candidates and preclinical research. Non-cash share-based compensation expense was $9.3 million for the three months ended June 30, 2021, an increase of $2.8 million as compared to the same period in 2020.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses, including non-cash share-based compensation costs, were $170.1 million for the three months ended June 30, 2021, compared to $124.8 million for the three months ended June 30, 2020. The increase of $45.3 million was primarily due to increases in spending to support increased commercial sales of NURTEC ODT for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. Less than half of the SG&A expense was for commercial organization personnel costs, excluding non-cash share-based compensation expense. Non-cash share-based compensation expense was $16.3 million for the three months ended June 30, 2021, an increase of $11.0 million as compared to the same period in 2020. The increase in non-cash share-based compensation expense was primarily due to the amortization of the Company’s annual equity incentive awards that were granted in the first quarter of 2021.

Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended June 30, 2021, of $210.6 million, or $3.23 per share, compared to $180.9 million, or $3.08 per share for the same period in 2020. Non-GAAP adjusted net loss for the three months ended June 30, 2021 was $170.9 million, or $2.62 per share, compared to $150.0 million, or $2.55 per share for the same period in 2020. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, non-cash interest expense related to the accounting for mandatorily redeemable preferred shares and liability related to sale of future royalties, changes in the fair value of derivatives, gains or losses from equity method investment, collaboration and license upfront expenses, and accrued development milestone payments. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

Cash, Restricted Cash, and Marketable Securities: Cash, restricted cash, and marketable securities as of June 30, 2021, was $368.0 million, compared to $570.9 million as of March 31, 2021. In addition, the Company has access to $225.0 million in delayed draw term loans under the Sixth Street Financing Agreement, and $164.8 million in Series B preferred share forward contracts in quarterly cash proceeds until the fourth quarter of 2024.

Conference Call Information
As previously announced, the Company will hold a conference call to discuss its second quarter 2021 results today at 8:30 a.m. EDT. To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast, and accompanying slide presentation, can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the call will be made available for two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (domestic) or 201-612-7415 (international) with conference ID 13720712. An archived webcast will be available on Biohaven’s website.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, adjusted to exclude the items below. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. These measures exclude (i) non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, (ii) interest expense related to the accounting for our mandatorily redeemable preferred shares and liability related to sale of future royalties, which are in excess of the actual interest owed, (iii) changes in the fair value of derivative liability, which does not correlate to actual cash payment obligations in the relevant periods, (iv) gains or losses from equity method investment, which are non-cash and based on the financial results and valuation of another company that we did not manage or control, (v) collaboration and license upfront expenses, which the Company does not believe are normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing, and (vi) non-routine accrued development milestone expenses.

Biohaven believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Biohaven’s results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of Biohaven’s ongoing operating performance and are better able to compare Biohaven’s performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.