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CRISPR Therapeutics to Participate in the Canaccord Genuity 41st Annual Growth Conference

On August 5, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021 at 2:30 p.m. ET (Press release, CRISPR Therapeutics, AUG 5, 2021, View Source [SID1234585798]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following each presentation.

BridgeBio Pharma, Inc. Reports Second Quarter 2021 Financial Results and Business Update

On August 5, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, reported its financial results for the second quarter ended June 30, 2021 and provided an update on the Company’s operations (Press release, BridgeBio, AUG 5, 2021, View Source [SID1234585797]).

"We measure success by the number of meaningful medicines we are able to develop and deliver to patients. By that metric, our most significant accomplishment of the quarter was the approval of TRUSELTIQ (infigratinib) for patients with cholangiocarcinoma – our second FDA approval as a company and our first for a cancer treatment. All drug approvals are a team effort that extends far beyond BridgeBio. We thank the patient community, physicians, scientists and advocates for their commitment and drive. They made this approval possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Major milestones anticipated in the next 12 months for BridgeBio’s four core value drivers:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. In a previous Phase 3 study in ATTR-CM patients, participants receiving the current standard of care treatment demonstrated a decline in 6MWD of approximately 25 meters (m) from an average baseline of 351m at 12 months.1 From a comparable average 6MWD baseline in the ATTRibute-CM study, the Company is seeking to more potently halt the observed decline in acoramidis-treated participants. As a reminder, healthy elderly adults typically decline only 7m in 12 months.2 If the change from baseline in 6MWD in Part A is highly statistically significant (p < 0.01), BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the FDA.
Encaleret – Calcium-sensing receptor (CaSR) inhibitor for ADH1: Received Fast Track designation from the FDA. Early results from an ongoing Phase 2 proof-of-concept study shared at the Endocrine Society’s 2021 Annual Meeting (ENDO) in March 2021 showed normalization of blood calcium and urine calcium in 6 of 6 (100%) ADH1 participants. Additional data from the ongoing study are expected in the second half of 2021. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.
Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the first half of 2022. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with a prevalence of greater than 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in clinical development for achondroplasia that is designed to target the disease at its genetic source and the only orally administered product candidate in clinical-stage development.
BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): Received Fast Track designation from the FDA in May 2021. Investigational New Drug (IND) application cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in mid-2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases estimated in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio’s AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.
Recent pipeline progress and corporate updates:

FDA approval received for TRUSELTIQ (infigratinib) under the accelerated approval program for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. BridgeBio is eligible to receive upfront, regulatory and commercial milestone payments totaling up to approximately $2.45 billion USD through its strategic collaboration with Helsinn Group to co-develop and commercialize infigratinib in certain oncology indications.
Fast Track designation received from the FDA for BBP-812, BridgeBio’s AAV9 gene therapy candidate for Canavan disease. IND cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing. Canavan disease is an extremely rare genetic condition starting in infancy with an incidence of approximately one in 100,000 births worldwide.
Fast Track designation received from the FDA for infigratinib, an FGFR inhibitor, for the treatment of urothelial carcinoma (urinary tract and bladder cancer).
New Drug Application (NDA) acceptance from the Israeli Ministry of Health for NULIBRY (fosdenopterin) for injection to treat patients with molybdenum cofactor deficiency (MoCD) Type A. The FDA approved NULIBRY as the first therapy to reduce the risk of mortality in patients with MoCD Type A in February 2021. MoCD Type A is an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate.
First-in-human Phase 1 trial of BBP-711, a glycolate oxidase (GO) inhibitor to treat patients with hyperoxaluria, initiated in May 2021.
Research collaborations initiated with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh to identify and advance therapies for genetic diseases and cancers for a total of 23 partnerships among BridgeBio and leading academic and research institutions to date.
Non-exclusive, co-funded clinical collaboration initiated with Bristol Myers Squibb to study BBP-398, a potentially best-in-class SHP2 inhibitor, in combination with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations.
BridgeBio Pharma R&D Day: BridgeBio will hold a virtual R&D Day on Tuesday, October 12, 2021, from 8:30 am ET – 11:30 am ET. The event will be webcast and registration information can be found here.
Second Quarter 2021 Financial Results:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $898.4 million as of June 30, 2021, compared to $607.1 million as of December 31, 2020. The net increase in balance of $291.3 million is attributed to $731.4 million in net proceeds received from the issuance of our 2.25% Convertible Senior Notes due 2029 (the 2029 Notes) in January 2021 and $30.2 million in upfront payment and reimbursements received in connection with our License and Collaboration Agreement with Helsinn Healthcare S.A. and Helsinn Therapeutics (U.S.), Inc. (collectively, Helsinn) , which became effective in April 2021, and $25.0 million in net proceeds from our Amended Loan and Security Agreement with Hercules Capital, Inc. in April 2021 (the Amended Hercules Term Loan). The cash receipts were partially offset by a $61.3 million payment related to capped call options and a $50.0 million payment to repurchase shares of BridgeBio common stock, both in relation to the issuance of our 2029 Notes. In connection with our acquisition of Eidos Therapeutics, Inc. (Eidos) in January 2021, we paid $63.6 million in direct transaction costs and $21.3 million to Eidos stockholders who elected cash settlement. The remaining change of $299.1 million primarily related to payments of interest and operating costs and expenses.

Cash, cash equivalents and marketable securities, excluding restricted cash, decreased by $102.9 million compared to our balance as of March 31, 2021, which was $1,001.3 million. The decrease in cash is mainly due to cash used primarily related to our operating costs and expenses and partially offset by the payments received from Helsinn and proceeds from the Amended Hercules Term Loan as also discussed above.

Revenues

Total revenues for the three and six months ended June 30, 2021 were $54.0 million and $54.5 million, respectively. Our revenues mainly include upfront and milestone payments arising from the License and Collaboration Agreement with Helsinn and the License Agreement between our affiliate Navire Pharma, Inc. and LianBio.

Operating Costs and Expenses

Operating costs and expenses for the three and six months ended June 30, 2021 were $148.0 million and $316.0 million, respectively, as compared to $124.6 million and $227.1 million for the same periods in the prior year. The increases in operating costs and expenses of $23.4 million and $88.9 million, respectively, during the periods were attributable to the increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, as well as an increase in stock-based compensation related to the achievement of various performance-based milestone compensation arrangements tied to regulatory and development milestones. Stock-based compensation for the three and six months ended June 30, 2021 was $32.0 million and $66.9 million, respectively, as compared to $18.4 million and $28.6 million for the same periods in the prior year. Amounts for the three and six months ended June 30, 2021 reflect the reduction in operating costs and expenses arising from cost sharing recognized under our License and Collaboration Agreement with Helsinn.

Our research and development expenses have not been significantly impacted by the global COVID-19 pandemic for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on our operating costs and expenses is currently unknown.

Bio-Techne Declares Dividend

On August 5, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended June 30, 2021 (Press release, Bio-Techne, AUG 5, 2021, View Source [SID1234585795]). The quarterly dividend will be payable August 27, 2021 to all common shareholders of record on August 16, 2021. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

Bayer-Strong-growth-guidance-upgrade

On August 5, 2021 Bayer Group reported strong growth in the second quarter of 2021 (Press release, Bayer, AUG 5, 2021, View Source [SID1234585794]). "Sales at all divisions increased by a double-digit percentage after adjusting for currency and portfolio effects, and we expect this positive sales momentum to continue in all our businesses. We are therefore upgrading our full-year guidance, and now anticipate higher sales and core earnings per share than in our previous forecast," said Werner Baumann, Chairman of the Board of Management, on Thursday. Presenting the company’s half-year financial report, he highlighted how "we have achieved major successes in developing and launching drugs, some of which have blockbuster potential. We have successfully expanded the launch of our cancer drug Nubeqa and are continuously surpassing our own expectations. We have continued to advance the launch of Verquvo for the treatment of symptomatic chronic heart failure, with approvals gained in the European Union and Japan, and we’re now in the process of launching Kerendia in the United States." The latter product was approved in July by the U.S. Food and Drug Administration for the treatment of adult patients with chronic kidney disease and type 2 diabetes. Bayer has also announced the acquisition of Vividion Therapeutics, as the company continues to make strides in implementing its strategy for the Pharmaceuticals Division. "Vividion’s unique technologies and special expertise will significantly strengthen our drug discovery capabilities," Baumann emphasized. Bayer recently formed its own cell and gene therapy platform as part of its transformation strategy for Pharmaceuticals. The platform already has potentially ground-breaking medical innovations in clinical development, such as a therapy for the treatment of Parkinson’s.

Group sales in the second quarter increased by 12.9 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 10.854 billion euros, after the prior-year period had been significantly impacted by the restrictions introduced in response to COVID-19. EBITDA before special items fell by 10.6 percent to 2.577 billion euros. Negative currency effects impacted sales by 524 million euros and EBITDA before special items by 153 million euros, with the latter also being diminished by allocations to provisions for variable compensation. EBIT came in at minus 2.281 billion euros (Q2 2020: minus 10.784 billion euros) after net special charges of 3.901 billion euros (Q2 2020: 12.511 billion euros). The special charges related primarily to the previously announced allocation to provisions – in the discounted amount of around 3.5 billion euros – in connection with the glyphosate litigations. Other special charges related to impairments and restructuring. Net income amounted to minus 2.335 billion euros (Q2 2020: minus 9.548 billion euros), while core earnings per share from continuing operations increased by 1.3 percent to 1.61 euros.

Free cash flow declined by 17.8 percent to 1.152 billion euros. Net financial debt as of June 30, 2021, increased to 34.361 billion euros, up 1.3 percent from March 31, 2021. Cash inflows from operating activities and positive currency effects almost offset the outflow for the dividend payment and settlement payments for litigations in the United States.

Crop Science grows sales in all regions

In the agricultural business (Crop Science), Bayer increased sales by 10.6 percent (Fx & portfolio adj.) to 5.021 billion euros, with growth in all regions. The division registered double-digit percentage gains in Latin America and Asia/Pacific as well as significant growth in North America after adjusting for currency and portfolio effects. Fungicides (Fx & portfolio adj. plus 22.9 percent) and Herbicides (Fx & portfolio adj. plus 16.2 percent) achieved particularly strong gains. Fungicides registered a significant increase in volumes, primarily in Latin America thanks to the Fox Xpro product, and also in North America due to the launch of new products such as Delaro Complete. The increase in sales at Herbicides was driven by increased volumes and prices, especially in North America, which saw higher volumes for XtendiMax and increased prices for Roundup. Business was also up at Soybean Seeds & Traits, which recorded growth of 9.1 percent (Fx & portfolio adj.) thanks to higher volumes in North America. Sales at Corn Seed & Traits advanced by 8.6 percent (Fx & portfolio adj.), with business benefiting in particular from increased volumes in Latin America and higher prices in North America.

EBITDA before special items at Crop Science decreased by 25.4 percent to 1.018 billion euros, giving a margin of 20.3 percent. Higher prices and volumes along with contributions from ongoing efficiency programs only partly offset an increase in costs, and particularly in the cost of goods sold. Earnings were also diminished by a negative product mix, currency effects of 111 million euros, and the later receipt of license revenues.

Pharmaceuticals raises sales and earnings

Sales of prescription medicines (Pharmaceuticals) rose by 16.2 percent (Fx & portfolio adj.) to 4.494 billion euros. The division’s business showed a robust recovery from the COVID-19 restrictions, particularly in the areas of ophthalmology, women’s healthcare and radiology, while other products such as the oral anticoagulant Xarelto and the newly launched cancer drug Nubeqa also generated tangible growth. Xarelto sales increased by 12.6 percent (Fx & portfolio adj.), largely as a result of significantly expanded volumes in China and Russia. Sales of the ophthalmology drug Eylea were up by 27.4 percent (Fx & portfolio adj.), mainly due to very strong growth as a result of high demand in Europe

EBITDA before special items at Pharmaceuticals increased by 3.0 percent to 1.409 billion euros, driven by the strong growth in sales. This resulted in a margin of 31.4 percent. Research and development expenses increased against the low prior-year figure and were partly attributable to the cell and gene therapy unit. Earnings were also diminished by an increase in the cost of goods sold, expenses for product launches, and a negative currency effect of 26 million euros.

Consumer Health delivers growth and increases profitability

Sales of self-care products (Consumer Health) increased by 12.8 percent (Fx & portfolio adj.) to 1.290 billion euros, with growth in all regions and categories following a soft prior-year quarter. Business benefited from continued high demand in Nutritionals, which saw sales rise by 15.7 percent (Fx & portfolio adj.), and from a strong allergy season in North America, which resulted in a 15.8 percent increase (Fx & portfolio adj.) in sales in the Allergy & Cold category.

EBITDA before special items at Consumer Health advanced by 9.4 percent to 278 million euros. As a result, the EBITDA margin before special items improved by 0.5 percentage points to 21.6 percent. The growth in earnings was primarily driven by the division’s strong business performance and continuous cost management efforts while allowing for additional investments in marketing as part of new product launches and accounting for negative currency effects of 20 million euros.

Outlook: Bayer optimistic for remainder of the year

Following the good business performance in the first half of 2021, Bayer is also optimistic for the remainder of the year and is raising its guidance accordingly. After adjusting for currency effects (i.e. based on the average monthly exchange rates in 2020), the company now expects to post sales of approximately 44 billion euros (previously: approximately 42 billion to 43 billion euros). This now corresponds to an increase of around 6 percent (previously: about 3 percent) on a currency- and portfolio-adjusted basis. Bayer now expects to generate an EBITDA margin before special items of around 26 percent (previously: around 27 percent) on a currency-adjusted basis. This would continue to correspond to EBITDA before special items of 11.2 billion to 11.5 billion euros on a currency-adjusted basis. Core earnings per share are now expected to come in at approximately 6.40 to 6.60 euros on a currency-adjusted basis (previously: approximately 6.10 to 6.30 euros). Free cash flow is now projected to amount to around minus 2 billion to minus 3 billion euros on a currency-adjusted basis (previously: around minus 3 billion to minus 4 billion euros). In addition, the company now expects net financial debt at the end of the year to come in at approximately 36 billion euros (previously: approximately 36 billion to 37 billion euros) on a currency-adjusted basis.

Based on the closing rates on June 30, 2021, the company now expects to generate sales of approximately 43 billion euros (previously: approximately 41 billion euros) for fiscal 2021. This now corresponds to an increase of approximately 6 percent (previously: approximately 3 percent) on a currency- and portfolio-adjusted basis. Bayer is now targeting an EBITDA margin before special items of approximately 25 percent (previously: approximately 26 percent). This would now correspond to EBITDA before special items of 10.6 billion to 10.9 billion euros (previously: 10.5 billion to 10.8 billion euros). Core earnings per share are now projected to come in at approximately 6.00 to 6.20 euros (previously: approximately 5.60 to 5.80 euros). Free cash flow is now expected to amount to around minus 2 billion to minus 3 billion euros (previously: around minus 3 billion to minus 4 billion euros), while net financial debt is now forecast to come in at around 35 billion euros (previously: around 35 billion to 36 billion euros).

Bayer links core financial instrument to ambitious sustainability targets

The company also made good progress in the area of sustainability. For example, Bayer recently amended its existing 4.5-billion-euro revolving credit facility by linking it to climate protection, creating a link between one of its financial instruments and its sustainability targets for the first time. The amendment incorporated the company’s greenhouse gas emission reduction targets into the revolving credit facility: if Bayer misses its reduction targets, it will make a compensation payment to a charitable organization. Through this amendment, Bayer has emphasized its commitment to achieving climate neutrality by 2030 and its holistic sustainability strategy.

After launching an initiative to help farmers sequester carbon in the soil in 2020, Bayer recently extended this decarbonization program to Europe. In addition, the long-term contraceptive Mirena has been added to the product catalogs of the United Nations Population Fund (UNFPA) and the United States Agency for International Development (USAID) for distribution in low- and mid-income countries. This represents a milestone in providing women in these countries with access to family planning. Bayer is investing 250 million euros in Turku, Finland, to expand and modernize the production of contraceptives.

Athenex Provides Second Quarter 2021 Corporate and Financial Update

On August 5, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that corporate and financial update for the second quarter ended June 30, 2021 (Press release, Athenex, AUG 5, 2021, View Source [SID1234585793]).

"During the second quarter, we held a Type A meeting with the FDA to discuss the path forward for oral paclitaxel and encequidar in metastatic breast cancer and the deficiencies that were raised in the Complete Response Letter (CRL) we received in February," said Johnson Lau, Chief Executive Officer of Athenex. "The FDA has indicated that a well-designed and well-conducted trial may adequately address these deficiencies. We are now evaluating the optimal design for a new clinical study which we plan to present to the FDA in the fourth quarter of 2021. We are continuing to advance oral paclitaxel in angiosarcoma towards registration."

"Our acquisition of Kuur Therapeutics and its innovative allogeneic CAR-NKT technology was a strategically important development for Athenex and we believe it has the potential to unlock tremendous value," continued Dr. Lau. "Kuur’s technology, combined with our TCR program, could propel us into a leadership position in cell therapy. We are pleased with the smooth integration of the Kuur team and operations to date and look forward to providing further updates as the programs advance."

Second Quarter 2021 and Recent Business Highlights

Clinical Programs

Oral Paclitaxel and Encequidar

Athenex held a Type A meeting with the US Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer during second quarter 2021. The Company is evaluating the optimal design for a new clinical study which it plans to present to the FDA in 4Q 2021.
An abstract "Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of oral paclitaxel + encequidar in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies" has been accepted for e-Poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021.
Cell Therapy

Presented data from a Phase 1 study (GINAKIT2) of KUR-501 in neuroblastoma at the annual meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2021. The data showed one complete response and one partial response out of 11 evaluable and heavily pre-treated pediatric neuroblastoma patients. The therapy was well tolerated with only one Grade 2 CRS.
Continued to enroll patients in a Phase 1 study (ANCHOR) evaluating KUR-502 in patients with relapsed/refractory CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
Received IRB approval to conduct a Phase 1 trial of TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 positive solid tumors).
Commercial Update

Klisyri (tirbanibulin)

Almirall, S.A. (BLM: ALM), Athenex’s partner, received marketing authorization of Klisyri from the European Commission in July 2021 for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. The approval followed receipt of a positive opinion from the CHMP of the European Medicines Agency in May 2021.
Athenex entered into license agreements for tirbanibulin with Seqirus (a subsidiary of CSL Limited) and AVIR Pharma, expanding its international commercial partnerships for tirbanibulin in Australia and New Zealand, and Canada, respectively.
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 34 products with 61 SKUs.
Athenex Pharma Solutions (APS) currently markets 4 products with 16 SKUs.
503B operations at the Dunkirk Facility expected to commence in Q4 2021.
Corporate Update

Athenex has accepted the resignation of its Chief Financial Officer, Randoll Sze, effective August 13, 2021. Mr. Steven Adams, the company’s current Corporate Controller, will take on the role of Interim Chief Accounting Officer until a permanent CFO is appointed.
Key Anticipated Milestones

Plan to discuss the design of a new clinical study for oral paclitaxel in metastatic breast cancer with the FDA in Q4 2021
Launch of Klisyri in a major European market in 2H 2021
Abstract on the ANCHOR Phase 1 study submitted to ASH (Free ASH Whitepaper) 2021
Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors) to initiate enrollment in 3Q 2021
Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
Second Quarter 2021 Financial Highlights

Revenues from product sales decreased to $21.4 million for the three months ended June 30, 2021, from $40.2 million for the three months ended June 30, 2020, a decrease of $18.8 million or 47%. This decrease was attributable to a decline in APD product sales of $20.4 million primarily as the result of a decrease in demand for COVID-19 related drugs from the prior year, including some significant non-recurring orders of approximately $14.1 million. In addition, in the first half of 2021, we experienced significant COVID-related challenges in our Indian supply chain and to a lesser extent in China. As a result, we were not able to receive some inventory from our partners located in these regions for a certain period of time. The Company also experienced a higher amount of product sales in 2020 as we started fulfilling demand for certain drugs used to treat patients hospitalized with COVID and demand for FDA shortage products. As a result, the product revenues in the second quarter of last year were particularly high, given the COVID pandemic had just started. Fluctuations in the infection rate and the spread of the global health pandemic and market demand may continue to significantly affect our product sales in the future. These were partially offset by an increase in 503B and contract manufacturing revenue of $1.5 million and $0.4 million, respectively.

License fees and other revenue increased by $0.5 million for the three months ended June 30, 2021. This increase was primarily due to $0.2 million grant revenue and $0.2 million in royalties received from Almirall for the sales of Klisyri after the product launch in the U.S. in February 2021.

Cost of sales for the three months ended June 30, 2021 totaled $19.7 million, a decrease of $13.3 million, or 40%, as compared to $33.0 million for the three months ended June 30, 2020. The decrease was primarily due to a decrease of $13.1 million in cost of APD product sales, generally in-line with the decrease in the product sales revenue. Additionally, cost of sales related to royalties for license income decreased by $1.2 million from the royalty payment incurred in 2020 on the license revenue from Xiangxue. Cost of 503B product sales increased by $1.3 million as production levels increased.

R&D expenses for the three months ended June 30, 2021 totaled $21.1 million, a decrease of $0.9 million, or 4%, as compared to $22.0 million for the three months ended June 30, 2020. This was primarily due to a decrease in regulatory costs, clinical operations, and preclinical operations. The decrease in these items was partially offset by increases in oral paclitaxel and encequidar API costs in preparation for product launch, together with increases in drug licensing costs, R&D related compensation expenses, and costs related to 503B and cell therapy development.

SG&A expenses for the three months ended June 30, 2021 totaled $21.2 million, an increase of $3.7 million, or 21%, as compared to $17.5 million for the three months ended June 30, 2020. This was primarily due to increase in professional fees and other expenses related to the acquisition of Kuur, increases in compensation related costs, change in fair value of contingent consideration and operating costs including insurance costs and IT costs. These increases were partially offset by a decrease in costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the CRL in February 2021.

Interest expense totaled $5.7 million and $1.6 million for the three months ended June 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income tax benefit for the three months ended June 30, 2021 amounted to $11.0 million, compared to income tax expense of $0.1 million for the same period in 2020. The income tax benefit in the current year is primarily the result of taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of our valuation allowance.

Net loss attributable to Athenex for the three months ended June 30, 2021 was $34.3 million, or ($0.33) per diluted share, compared to a net loss of $40.5 million, or ($0.50) per diluted share, in the same period last year.

As of June 30, 2021, the Company had cash and cash equivalents of $76.9 million, restricted cash of $16.5 million, and short-term investments of $53.3 million.

For further details on the Company’s financial results, including the results for the six months ended June 30, 2021, refer to the Form 10Q to be filed with the SEC.

Financial Guidance

In terms of product sales guidance, the Company is limiting financial guidance to the existing Athenex product portfolio only. In 2020, the Company recorded a significant amount of revenues from international customers as a result of the global pandemic. However, it does not see these revenues as recurring in nature. The Company continues to expand its product portfolio. The Company is affirming the guidance it provided on May 6, 2021, as it currently expects its product sales in 2021, excluding any royalties from Klisyri, to be in line with 2020 levels.

Cash Conservation Update

As of June 30, 2021, the Company had cash and cash equivalents, restricted cash and short-term investments of $146.7 million. Given uncertainty stemming from the CRL for oral paclitaxel, the Company identified and adopted certain cash conservation measures. Considering these initial measures, and based on our current operating plan, the Company now expects that its cash and cash equivalents, restricted cash and short-term investments as of June 30, 2021, will enable it to meet its current operational liquidity needs and fund operations into 4Q 2022.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, August 5, 2021, at 8:00 am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed by audio webcast here and also under "Events and Presentations" at the Investor Relations section of the Company’s website, located at View Source