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G1 Therapeutics Provides Second Quarter 2019 Corporate and Financial Update

On August 7, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2019 (Press release, G1 Therapeutics, AUG 7, 2019, View Source [SID1234538364]).

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"Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people being treated with chemotherapy for small cell lung cancer and triple-negative breast cancer. We are pleased that the FDA has granted Breakthrough Therapy Designation based on myelopreservation data in small cell lung cancer, an important step toward making trilaciclib available to these patients. We look forward to working with the FDA during our pre-NDA meeting next month. We have also initiated parallel discussions with the FDA regarding promising data in metastatic triple-negative breast cancer, which showed improved overall survival," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "In addition, we continue to make rapid progress across our pipeline, with emerging data suggesting that all three investigational therapies – trilaciclib, lerociclib and G1T48 – have the potential to improve outcomes for women with breast cancer and be used in early stages of their disease."

Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D, added, "We will present new data on trilaciclib, lerociclib and G1T48 at the upcoming ESMO (Free ESMO Whitepaper) congress. Of note, we will report the first clinical data from approximately 25 patients in a Phase 1 trial of G1T48, our oral selective estrogen receptor degrader. Based on data from this trial, we are planning to initiate a pivotal trial in 2020 with G1T48 for the treatment of ER+, HER2- breast cancer in combination with a CDK4/6 inhibitor."

Clinical, Regulatory and Corporate Updates

Breakthrough Therapy Designation (BTD) granted for trilaciclib based on myelopreservation data in small cell lung cancer (SCLC) patients; U.S. and European regulatory filings on track for 2020: The company has received BTD from the U.S. Food and Drug Administration (FDA) based on positive myelopreservation data in small cell lung cancer patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions. The company expects to submit marketing applications in the U.S. and Europe in 2020.

Preliminary overall survival (OS) results from randomized Phase 2 trial demonstrated women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone: Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) (press release here). In June 2019, the company reported updated anti-tumor efficacy results that showed women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone (press release here). Detailed data from this trial will be presented at a medical meeting later this year.

Data on all three clinical-stage programs accepted for presentation at ESMO (Free ESMO Whitepaper) 2019 Congress: New clinical data on trilaciclib, lerociclib and G1T48 have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. Presentations include the first clinical data on G1T48, an oral selective estrogen receptor degrader (SERD), myelopreservation and efficacy data from the Phase 2 trilaciclib + chemotherapy + Tecentriq (atezolizumab) small cell lung cancer trial, and safety and tolerability data from the Phase 1b/2a lerociclib + Tagrisso (osimertinib) non-small cell lung cancer trial. The company will host a webcast on Sunday, Sept. 29 to review the data and provide an overview of development and commercial plans across the pipeline.

Additional data on trilaciclib reported at ASCO (Free ASCO Whitepaper) and MASCC/ISOO annual meetings: The company reported additional data from trilaciclib SCLC clinical trials at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2019 annual meetings. Pooled myelopreservation and patient-reported outcomes (PRO) data from all three trilaciclib SCLC trials presented at MASCC 2019 showed significant multilineage benefits across neutrophils, red blood cells and platelets, and significantly improved symptoms and function across multiple parameters over time compared to placebo.

Executive team update: In July, the company announced the appointment of Mark Avagliano as Chief Business Officer. Prior to joining G1, Mr. Avagliano was Vice President, Corporate Development at Pfizer Inc., where he was responsible for the evaluation, planning and execution of significant corporate level transactions and oversaw the Mergers and Acquisitions, Transactions and Valuations, and Out-licensing groups (press release here).

Board of Directors update: In June, current board member Garry Nicholson was named board chair, succeeding former chair Seth Rudnick, M.D. Additionally, Dr. Rudnick, Sir Andrew Witty and Fredric Eshelman, Pharm.D. were re-elected to the company’s Board of Directors.

Second Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $324.9 million as of June 30, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $32.6 million for the second quarter of 2019, compared to $21.7 million for the second quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.7 million for the second quarter of 2019, compared to $2.1 million for the second quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2019 were $23.5 million, compared to $18.4 million for the second quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2019 were $9.1 million, compared to $3.3 million for the second quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $30.7 million for the second quarter of 2019, compared to $20.9 million for the second quarter of 2018.

2019 Guidance: the company expects to end the year with $260-$270 million in cash and cash equivalents.

Anticipated Milestones for 2H 2019

Present new clinical results for trilaciclib, lerociclib and G1T48 at the ESMO (Free ESMO Whitepaper) 2019 Congress, being held Sept. 27-Oct. 1. The company will host an onsite event/webcast on Sunday, Sept. 29 to review the data.

Complete meetings with the FDA and provide regulatory update for trilaciclib, including NDA filing timeline.

Present preliminary OS findings from trilaciclib mTNBC trial at a medical meeting in 2H19

Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

In 4Q19, identify dose and schedule of lerociclib and G1T48 for pivotal trials in breast cancer in 2020.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter 2019 ended June 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 7989125. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Sierra Oncology to Present at the Wedbush PacGrow Healthcare Conference in New York

On August 7, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company at 2:30 pm ET on Wednesday, August 14 at the Wedbush PacGrow Healthcare Conference being held in New York (Press release, Sierra Oncology, AUG 7, 2019, View Source [SID1234538351]).

A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

Ionis Reports Second Quarter 2019 Financial Results

On August 7, 2019 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported its financial results for the second quarter and year-to-date 2019 and recent business highlights (Press release, Ionis Pharmaceuticals, AUG 7, 2019, View Source [SID1234538350]).

"We enter the second half of 2019 in a position of substantial financial strength driven by revenue growth of more than 75 percent. SPINRAZA’s blockbuster performance, with over $1 billion in net sales in the first half, contributed significantly to our strong financial results. There are approximately 8,400 patients on SPINRAZA, an increase of approximately 12 percent compared to last quarter. Product sales from TEGSEDI’s second full quarter on the market also contributed to our strong first half results. Additionally, WAYLIVRA is on track to launch in Europe this quarter. With three medicines commercialized in the last three years, an advancing technology and a pipeline of over 40 medicines, we are positioned to continue delivering value to patients and shareholders through this year and beyond," said Stanley T. Crooke, M.D., Ph.D., chairman of the board and chief executive officer of Ionis.

"Our strong year-to-date financial results were driven by continued revenue growth across both commercial and R&D revenues. These results put us on track to meet or potentially improve upon our 2019 guidance. We are also on track to achieve our fourth consecutive year of operating income and our third consecutive year of net income, both on a non-GAAP basis. We believe our ability to be profitable while investing in commercial activities, fully exploiting our pipeline and advancing our technology, clearly sets us apart from our peers," said Elizabeth L. Hougen, chief financial officer of Ionis.

Year-to-Date 2019 Financial Results and Highlights

Year-to-date revenues increased more than 75 percent
Commercial revenue from SPINRAZA (nusinersen) royalties increased more than 30 percent to $130 million for the first half of 2019 compared to 2018.
TEGSEDI (inotersen) product sales were $17 million in the first half of 2019, reflecting a more than 40 percent increase in the second quarter compared to the first quarter.
R&D revenue nearly doubled in the first half of 2019 compared to 2018.
Significant net income for the first half of 2019 puts Ionis on track for its third consecutive year of net income
Operating income and net income significantly improved to $103 million and $84 million, respectively, in the first half of 2019 compared to 2018.
Non-GAAP operating income increased by more than 20-fold in the first half of 2019 compared to 2018.
Non-GAAP net income increased by approximately 10-fold in the first half of 2019 compared to 2018.
Maintained substantial cash position of $2.3 billion while aggressively investing broadly across Ionis’ business
All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of non-GAAP and GAAP measures, which is provided later in this release.

"In addition to our commercial medicines, we have a broad and advancing pipeline of potentially transformational medicines we are moving toward the market. In our late-stage pipeline, our medicines targeting Huntington’s disease and SOD1-ALS are progressing in Phase 3 studies, both with the potential to support registration. Our LICA medicines targeting Lp(a)-driven cardiovascular disease and TTR amyloidosis are on track to initiate Phase 3 programs this year. Positive results from our HBV program, our advancing FXI program, which is nearing completion, and the initiation of multiple Phase 2 studies demonstrate the potential value in our mid-stage pipeline. All of these potentially transformational medicines demonstrate the ability of our technology to address a broad range of diseases from rare diseases to those affecting millions of patients," said Brett P. Monia, chief operating officer at Ionis.

Recent Business Highlights

SPINRAZA – a worldwide foundation-of-care for the treatment of patients of all ages with spinal muscular atrophy (SMA)
Worldwide sales of SPINRAZA increased by nearly 30 percent to $1 billion in the first half of 2019 compared to 2018.
Patients on SPINRAZA treatment increased by approximately 12 percent, compared to last quarter, to approximately 8,400 patients across global commercial, clinical and expanded access settings.
Biogen believes the global SMA opportunity to be significantly greater than previous estimates, with over 45,000 patients in markets where Biogen has a direct presence.
TEGSEDI – launch underway in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
Product sales were $17 million in the first half of 2019 and $10 million in the second quarter of 2019.
On track to launch in England this month following a positive reimbursement recommendation from NICE.
Launch in additional EU countries planned; launch in Latin America planned with PTC Therapeutics.
WAYLIVRA (volanesorsen) – the only medicine approved in the EU for the treatment of adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis
On track to launch in the EU this month, beginning in Germany, with additional EU country launches planned in 2020.
Encouraging discussions continued with the U.S. Food and Drug Administration to clarify a path forward in the U.S.
Received $6 million milestone payment from PTC Therapeutics for the EU approval of WAYLIVRA in the second quarter.
Achieved the primary endpoint of a statistically significant reduction in triglyceride levels and an important secondary endpoint of a statistically significant reduction in liver fat with good safety and tolerability in patients with familial partial lipodystrophy (FPL) in the BROADEN study.
Ionis achieved positive results in its program to treat patients with hepatitis B viral infection as reported by GSK.
Ionis initiated a Phase 2 study of IONIS-FB-LRx in patients with geographic atrophy secondary to age-related macular degeneration.
Ionis initiated a Phase 2 study of IONIS-PKK-LRx in patients with hereditary angioedema.
Ionis appointed Joan E. Herman, MBA, MS, president and chief executive officer of Herman and Associates, LLC to the Ionis board of directors.
Key Upcoming Events

Ionis and Akcea plan to initiate the Phase 3 program for AKCEA-TTR-LRx in patients with TTR amyloidosis before the end of 2019.
Novartis plans to initiate the Phase 3 HORIZON cardiovascular outcomes study of AKCEA-APO(a)-LRx (TQJ230) in patients with elevated Lp(a)-driven cardiovascular disease before the end of 2019.
Ionis and Akcea plan to present data from the Phase 1/2 study of AKCEA-TTR-LRx in healthy volunteers in September 2019 at the European ATTR Amyloidosis meeting and at the Heart Failure Society of America.
Roche plans to present data from the open label extension portion of the Phase 1/2 study of IONIS-HTTRx (RG6042) in patients with Huntington’s disease.
Ionis plans to initiate a Phase 2 study of IONIS-FB-LRx in a second indication under Ionis’ collaboration with Roche to develop medicines for the treatment of complement-mediated diseases.
Ionis and its partners plan to report data from the HBV and FXI clinical programs at future medical conferences.
Ionis and Akcea plan to report top line results from Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx in 1H 2020.
Revenue

Ionis’ revenue in the three and six months ended June 30, 2019 was $164 million and $461 million, respectively, compared to $118 million and $262 million for the same periods in 2018 and was comprised of the following (amounts in millions):

For the first half of 2019, Ionis significantly increased both commercial revenue and R&D revenue compared to the same period in 2018. Commercial revenue from SPINPRAZA royalties increased over 30 percent primarily due to increased SPINRAZA product sales. TEGSEDI product sales increased more than 40 percent over the first quarter of this year and were another important source of commercial revenue for Ionis.

Ionis’ R&D revenue substantially increased in the first half of 2019 compared to the same period in 2018 primarily due to the following:

$150 million the Company earned from Novartis when Novartis licensed AKCEA-APO(a)-LRx;
$35 million the Company earned from Roche when Roche enrolled the first patient in the Phase 3 study of IONIS-HTTRx in patients with Huntington’s disease; and
$20 million the Company earned from Alnylam when Alnylam licensed Ionis’ technology to Regeneron.
Operating Expenses

Operating expenses for the three and six months ended June 30, 2019 on a GAAP basis were $183 million and $358 million, respectively, and on a non-GAAP basis were $141 million and $271 million, respectively. These amounts compare to GAAP operating expenses for the three and six months ended June 30, 2018 of $168 million and $316 million, respectively, and non-GAAP operating expenses of $134 million and $253 million, respectively. The increase in operating expenses was principally due to Ionis’ investment in the global launch of TEGSEDI and preparing to launch WAYLIVRA in the EU.

Income Tax Expense

Ionis recorded an income tax benefit of $7 million for the three months ended June 30, 2019 and income tax expense of $24 million for the six months ended June 30, 2019. Ionis’ income tax expense in the first half of this year was primarily due to Ionis’ expectation that it will generate U.S. federal and state taxable income in 2019.

Net Loss Attributable to Noncontrolling Interest in Akcea

At June 30, 2019, Ionis owned approximately 76 percent of Akcea. The shares of Akcea third parties own represent an interest in Akcea’s equity that Ionis does not control. However, because Ionis continues to maintain overall control of Akcea through its voting interest, Ionis reflects the assets, liabilities and results of operations of Akcea in Ionis’ consolidated financial statements. Ionis reflects the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line called "Net loss attributable to noncontrolling interest in Akcea" on Ionis’ statement of operations. Ionis’ net loss attributable to noncontrolling interest in Akcea for the three and six months ended June 30, 2019 was $9 million and $3 million, respectively, compared to $16 million and $25 million for the three and six months ended June 30, 2018, respectively.

Net Income (Loss) Attributable to Ionis Common Stockholders

On a GAAP basis, Ionis reported net loss and net income attributable to Ionis’ common stockholders of $1 million and $84 million for the three and six months ended June 30, 2019, respectively, compared to a net loss of $40 million and $42 million for the same periods in 2018. On a non-GAAP basis, Ionis reported net income attributable to Ionis’ common stockholders of $38 million for the three months ended June 30, 2019, compared to a net loss attributable to Ionis’ common stockholders of $10 million for the same period in 2018. For the six months ended June 30, 2019, Ionis reported net income attributable to Ionis’ common stockholders of $162 million, compared to $15 million for the same period in 2018, all on a non-GAAP basis. The increase was primarily due to increases in revenue.

For the three months ended June 30, 2019, basic and diluted net loss per share were $0.01, compared to $0.29 for the same period in 2018. For the six months ended June 30, 2019, basic and diluted net income per share were $0.62 and $0.61, respectively, compared to basic and diluted net loss per share of $0.30 for the same period in 2018. All amounts are on a GAAP basis.

Balance Sheet

Ionis maintained its strong balance sheet, ending the second quarter of 2019 with cash, cash equivalents and short-term investments of $2.3 billion, compared to $2.1 billion at December 31, 2018.

Webcast and Conference Call

Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast conference call to discuss this earnings release and related activities. Interested parties may listen to the call by dialing 877-443-5662 or access the webcast at www.ionispharma.com. A webcast replay will be available for a limited time.

ANI Pharmaceuticals Reports Second Quarter Results

On August 7, 2019 ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) reported its financial results for the three and six months ended June 30, 2019 and reaffirmed its previously issued guidance for adjusted non-GAAP EBITDA and adjusted non-GAAP earnings per share, while updating its 2019 financial guidance for net revenues (Press release, ANI Pharmaceuticals, AUG 7, 2019, View Source [SID1234538349]). The Company will host its earnings conference call this morning, August 7, 2019, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 3823848.

Financial Summary

(a) See ANI’s Form 10-Q filed August 7, 2019 for discussion of year-to-date results.

(b) See Table 3 for US GAAP reconciliation.

Arthur S. Przybyl, President and CEO, stated,

"ANI had a strong second quarter, generating net revenues of $54.4 million, an increase of 15% over the prior year period, and record adjusted non-GAAP EBITDA of $23.7 million, an increase of 24% over the prior year period. More importantly, we remain on track to file our supplemental NDA for Cortrophin Gel in the first quarter of 2020.

Generic product revenues increased 20% over the prior year period and we launched one new generic product in late June, Ranitidine capsules. We also received FDA approval for 250 mg/5 ml Vancomycin Oral Solution, which we intend to launch in the third quarter.

During the second quarter, we continued to add to our generic portfolio, through an April distribution agreement with a specialty injectable manufacturer and the June acquisition of seven development stage generic products, which expanded our pipeline of injectable drugs to six."

ANI Updates Guidance for Net Revenues for the Full Year 2019

ANI has updated its full year guidance for net revenues due to the competitive landscape of the Methylphenidate ER market. ANI’s guidance for adjusted non-GAAP EBITDA and adjusted non-GAAP earnings per diluted share remains unchanged from previously issued guidance.

Revised guidance for 2019 net revenues of $220 million to $226 million reflects sales growth of between 9% and 12% over 2018 full year actual results. Previous guidance for net revenues was $231 million to $245 million.

ANI’s estimates are based upon actual results for the six months ending June 30, 2019 and projected results for the remaining six months of the year. ANI’s full year 2019 financial guidance reflects management’s current assumptions regarding customer relationships, product pricing, prescription trends, competition, inventory levels, cost of sales, operating costs, timing of research and development spend, taxes, and the anticipated timing of future product launches and other key events. For the twelve months ending December 31, 2019, ANI is providing guidance on net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share.

Generic Pharmaceutical Products

Second Quarter Net Revenues – Results and Update

Net revenues from sales of generic pharmaceuticals increased 20% to $36.3 million from $30.2 million in the prior period, primarily due to the launch of Ezetimibe-Simvastatin, Candesartan, and other products launched in 2018 and 2019, as well as increased unit sales of Vancomycin.

Key Generic Pipeline Product

Branded Pharmaceutical Products

Second Quarter Net Revenues – Results and Update

Net revenues from sales of branded pharmaceuticals increased 33% to $14.0 million from $10.5 million in the prior period, primarily due to sales of Arimidex and Casodex, which were launched under ANI’s label in July 2018 and sales of Atacand and Atacand HCT, which were launched under ANI’s label in October 2018. Prior to the launch under the ANI label, net revenues generated by these products was recorded via royalties received and was reported as Royalty and Other.

Key Brand Pipeline Products

Product

Vancocin for Oral Solution Update

ANI is currently advancing a commercialization effort for Vancocin for oral solution. ANI filed a prior approval supplement ("PAS") in September 2018 and it was approved in June 2019. This product will be manufactured at ANI’s site in Baudette, Minnesota and will compete in a market that currently exceeds $450 million annually.

Cortrophin Gel Re-commercialization Update

ANI continues to successfully progress our Cortrophin re-commercialization program. Significant accomplishments since the first quarter 2019 press release (dated May 9, 2019) include:

The completion of a third commercial scale batch of Corticotropin API. This batch was analytically consistent with previously manufactured batches and met all specifications. ANI expects to complete API process validation and registration stability batch manufacturing in the third quarter of 2019.
The initiation of viral clearance studies, which are expected to be completed in the third quarter of 2019.
The manufacture of two commercial scale batches of Cortrophin Gel using commercial scale API. ANI intends to complete the third and final registration batch of drug product in the third quarter of 2019.
ANI remains on track to file a supplemental NDA in the first quarter of 2020.

For further details, please see ANI’s Cortrophin Gel Re-commercialization Milestone Update in Table 5.

Contract Manufacturing

Second Quarter Net Revenues – Results and Update

Contract manufacturing revenues increased 120% to $3.7 million from $1.7 million in the prior year period, primarily due to the impact of contract manufacturing revenues from ANI’s Canadian subsidiary, ANI Pharmaceuticals Canada Inc. ("ANI Canada"), which was acquired in August 2018.

Royalty and Other

Second Quarter Net Revenues – Result and Update

Royalty and other decreased 91% to $0.4 million from $4.9 million, primarily due to the launches of Atacand, Atacand HCT, Arimidex, and Casodex under the ANI label in the second half of 2018. The net revenues from those products are now included in the net sales of branded pharmaceutical products. This decline was tempered by product development and lab services net revenues from ANI Canada.

Key Royalty Product: Yescarta

ANI is entitled to a percentage of global Yescarta net sales as well as a portion of certain product milestones, such as the recent positive opinion issued by the European Medicines Agency ("EMA") Committee for Medicinal Products for Human Use ("CHMP").

Operating Expenses

Operating expenses increased to $45.1 million for the three months ended June 30, 2019, from $40.0 million in the prior year period. The increase was primarily due to a $4.2 million increase in selling, general, and administrative expense as compared with the prior period, as a result of costs related to the new ANI Canada subsidiary, increased U.S.-based headcount and pharmacovigilance compliance costs in continued support of the expansion of our commercial portfolio, higher GDUFA and PDUFA user fees paid to the U.S. FDA, higher legal fees, and increased sales and marketing-related costs. In addition, depreciation and amortization increased by $1.2 million, primarily due to additional amortization expense associated with a March 2019 asset acquisition and a January 2019 royalty buyout payment related to a prior period asset acquisition. These increases were partially offset by a $1.0 million decrease in cost of sales.

Cost of sales as a percentage of net revenues decreased to 29% during the three months ended June 30, 2019, from 35% during same period in 2018. The decrease was primarily due to lower royalty expense resulting from a royalty buy out and lower sales of products under profit-sharing arrangements.

Net Income and Diluted Earnings per Share

Net income was $6.6 million for the three months ended June 30, 2019, as compared to net income of $2.8 million in the prior year period. The effective consolidated tax rate excluding impacts of discrete items for the three months ended June 30, 2019 was 16.8%.

Diluted earnings per share for the three months ended June 30, 2019 was $0.53, based on 12,269 thousand diluted shares outstanding, as compared to diluted earnings per share of $0.23 in the prior year period. Adjusted non-GAAP diluted earnings per share was $1.44, as compared to adjusted non-GAAP diluted earnings per share of $1.13 in the prior year period. For a reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 4.

ANI Product Development Pipeline

ANI’s pipeline consists of 111 products, addressing a total annual market size of $5.2 billion, based on data from IQVIA. Of these 111 products, 106 were acquired and of these acquired products, ANI expects that at least 56 can be commercialized based on either CBE-30s or prior approval supplements filed with the FDA.

Non-GAAP Financial Measures

The Company’s fiscal 2019 guidance for adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share is not reconciled to the most comparable GAAP measure. This is due to the inherent difficulty of forecasting the timing or amount of items that would be included in a reconciliation to the most directly comparable forward-looking GAAP financial measures. Because a reconciliation is not available without unreasonable effort, it is not included in this release.

Adjusted non-GAAP EBITDA

ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.

Adjusted non-GAAP EBITDA is defined as net income/(loss), excluding tax expense, interest expense, depreciation, amortization, the excess of fair value over cost of acquired inventory, stock-based compensation expense, expense from acquired in-process research and development, gains, losses, and expenses related to the repurchase of convertible debt, expenses related to debt financing, transaction and integration expenses, and other income / expense. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided in Table 3.

Adjusted non-GAAP Net Income

ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by purchase accounting adjustments, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, and non-cash impairment charges. Management uses adjusted non-GAAP net income when analyzing Company performance.

Adjusted non-GAAP net income is defined as net income/(loss), plus the excess of fair value over cost of acquired inventory, stock-based compensation expense, transaction and integration expenses, gains, losses, and expenses related to the repurchase of convertible debt, expenses related to debt financing, non-cash interest expense, depreciation and amortization expense, expense from acquired in-process research and development, and non-cash impairment charges, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided in Table 4.

Adjusted non-GAAP Diluted Earnings per Share

ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by purchase accounting adjustments, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, and non-cash impairment charges.

Management uses adjusted non-GAAP diluted earnings per share when analyzing Company
performance.

Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period, as adjusted for the dilutive effect of the convertible debt notes, when applicable. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided in Table 4.

VolitionRx Limited Schedules Second Quarter 2019 Earnings Conference Call and Business Update

On August 7, 2019 VolitionRx Limited (NYSE American: VNRX) reported it will host a conference call on Tuesday, August 13 at 8:30 a.m. Eastern time to discuss its financial and operating results for the second quarter of 2019 in addition to providing a business update (Press release, VolitionRX, AUG 7, 2019, View Source [SID1234538348]).

Event:

VolitionRx Limited Second Quarter 2019 Earnings and Business Update Conference Call

Date:

Tuesday, August 13, 2019

Time:

8:30 a.m. Eastern time

U.S. & Canada Dial-in:

1-877 407 9716 (toll free)

U.K. Dial-in:

0 800 756 3429 (toll free)

Toll/International:

1-201 493 6779

Conference ID:

13693585

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events that have taken place in the second quarter of 2019, and milestones for the remainder of 2019 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until August 27, 2019. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13693585.