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Intellia Therapeutics to Hold Conference Call to Discuss Fourth Quarter and Full-Year 2019 Earnings and Company Update

On February 20, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present fourth quarter and full-year 2019 financial results and operational highlights in a conference call on February 27, 2020 at 8 a.m. ET (Press release, Intellia Therapeutics, FEB 20, 2020, View Source [SID1234554563]).

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To join the call:

U.S. callers should dial 1-877-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com, beginning on February 27, 2020 at 12 p.m. ET.

Akari Therapeutics, Plc Announces Private Placement

On February 20, 2020 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported that it has entered into definitive agreements with certain accredited investors, the majority of whom are existing investors of the Company, including Dr. Ray Prudo, Akari’s Chairman, to receive gross proceeds of approximately $6 million through the private placement of its equity securities (Press release, Akari Therapeutics, FEB 20, 2020, View Source [SID1234554562]).

In connection with the offering, the Company will issue unregistered American Depository Shares (ADSs) at a purchase price of $1.70 per ADS. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one-half ADS. The warrants will have an exercise price of $2.20 per ADS, will be exercisable upon their issuance and will expire five years from the issuance date. The closing of the offering is expected to take place during or before the week of February 24, 2020, subject to the satisfaction of customary closing conditions.

Paulson Investment Company, LLC, is acting as the exclusive placement agent in connection with this offering.

The ADS and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon exercise of the warrants, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Puma Biotechnology Reports Fourth Quarter and Full Year Financial Results

On February 20, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Puma Biotechnology, FEB 20, 2020, View Source [SID1234554561]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2019, compared to the fourth quarter and full year 2018.

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the fourth quarter of 2019 was $58.7 million, compared to net product revenue of $61.1 million in the fourth quarter of 2018. Net product revenue for the full year 2019 was $211.6 million, compared to net product revenue of $200.5 million for the full year 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $11.2 million, or $0.29 per share, for the fourth quarter of 2019, compared to a net loss of $30.7 million, or $0.80 per share, for the fourth quarter of 2018. Net loss for the full year 2019 was $75.6 million, or $1.95 per share, compared to $113.6 million, or $2.99 per share, for the full year 2018.

Non-GAAP adjusted net income was $0.3 million, or $0.01 per share, for the fourth quarter of 2019, compared to non-GAAP adjusted net loss of $12.2 million, or $0.32 per share, for the fourth quarter of 2018. Non-GAAP adjusted net loss for the full year 2019 was $18.3 million, or $0.47 per share, compared to non-GAAP adjusted net loss of $26.7 million, or $0.70 per share, for the full year 2018. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2019 was $1.6 million, compared to net cash provided by operating activities of $7.1 million for the fourth quarter of 2018. Net cash provided by operating activities for the full year 2019 was $22.4 million, compared to net cash used in operating activities of $24.1 million for the full year 2018. At December 31, 2019, Puma had cash, cash equivalents and marketable securities of $111.6 million, compared to $165.4 million at December 31, 2018.

"During 2019, Puma made broad strides to increase global commercial access to NERLYNX by HER2-positive breast cancer patients, as well as to expand the label and potential therapeutic indications of NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our year concluded with a label expansion to address NERLYNX side effects, registration approval in Hong Kong and marketing approval in Singapore for NERLYNX, an expanded license agreement with Pierre Fabre, as well as several clinical data presentations at SABCS. We believe these regulatory, commercial, partnering and clinical milestones position Puma for improved results in 2020 and beyond."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) modifying the SUMMIT basket trial to expand the HER2-mutated breast cancer cohort in the first quarter of 2020; (ii) receiving a [U.S.] regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in the second quarter of 2020; (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the fourth quarter of 2020; (iv) reporting Phase II data from the HER-positive breast and cervical cancer cohorts from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (v) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (vi) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the fourth quarter of 2019, total revenue was $62.9 million, of which $58.7 million was net product revenue, $4.0 million was license revenue received from Puma’s sub-licensees, and $0.2 million was royalty revenue. This compares to total revenue of $71.1 million in the fourth quarter of 2018, of which $61.1 million was net product revenue and $10.0 million was license revenue received from Puma’s sub-licensees. For the year ended December 31, 2019, total revenue was $272.3 million, of which $211.6 million was net product revenue, $60.3 million was license revenue received from Puma’s sub-licensees and $0.4 million was royalty revenue. This compares to total revenue of $251.0 million for the year ended December 31, 2018, of which $200.5 million was net product revenue and $50.5 million was license revenue received from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $71.6 million for the fourth quarter of 2019, compared to $89.7 million for the fourth quarter of 2018. Total operating costs and expenses were $311.4 million for the full year 2019 compared to $345.7 million for the full year 2018.

Cost of Sales

Cost of sales was $10.1 million for the fourth quarter of 2019 and $36.8 million for the full year 2019, compared to $10.3 million for the fourth quarter of 2018 and $34.6 million for the full year 2018.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $31.3 million for the fourth quarter of 2019, compared to $41.0 million for the fourth quarter of 2018. Selling, general and administrative expenses for the full year 2019 were $141.7 million, compared to $146.2 million for full year 2018, a decrease of approximately $4.5 million. The decrease in SG&A expenses for the full year 2019 primarily related to decreases in stock-based compensation expense of approximately $7.0 million, and payroll and related costs of approximately $1.3 million. These decreases were partially offset by an increase in professional fees and expenses of approximately $2.7 million and an impairment loss of approximately $1.2 million.

Research and Development Expenses

Research and development expenses were $30.2 million for the fourth quarter of 2019, compared to $38.4 million for the fourth quarter of 2018. Research and development expenses for the full year 2019 were $132.9 million, compared to $164.9 million for the full year 2018. The decrease of approximately $32.0 million for the full year 2019 resulted primarily from decreases in stock-based compensation expense of approximately $22.6 million, internal R&D expense of approximately $4.7 million, clinical trial expenses of approximately $4.2 million, and consultant and contractor costs of approximately $0.5 million.

Total Other Income (Expenses)

Total other expenses were $2.5 million for the fourth quarter of 2019, compared to $12.1 million for the fourth quarter of 2018. Total other expenses were $36.5 million for the year ended December 31, 2019, compared to $18.9 million for the year ended December 31, 2018. The increase of $17.6 million during the full year 2019 compared to the full year 2018 primarily resulted from an increase in debt extinguishment loss of approximately $8.1 million, an increase in legal verdict expense of approximately $7.4 million, and an increase in interest expense of approximately $4.0 million, partially offset by an increase in interest and other income of approximately $1.9 million.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 20, 2020. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

PRA Health Sciences, Inc. Reports Fourth Quarter and Full Year 2019 Results and Provides First Quarter and Full Year 2020 Guidance

On February 20, 2020 PRA Health Sciences, Inc. ("PRA" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter and year ended December 31, 2019 (Press release, PRA Health Sciences, FEB 20, 2020, View Source [SID1234554560]).

"We are pleased with our financial results for the quarter and are delighted to have delivered double digit constant currency revenue growth and double digit adjusted earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the year, we strengthened our leadership in Strategic Solutions, Product Registration, and Symphony Health and we believe we are very well positioned for the coming year. In 2020, we will continue to focus on our key strategic initiatives and to providing broad and flexible services to our clients."

Net new business for our Clinical Research segment for the three months ended December 31, 2019 was $658.9 million, representing a net book-to-bill ratio of 1.21 for the period. This net new business contributed to an ending backlog of $4.7 billion at December 31, 2019.

For the three months ended December 31, 2019, revenue was $800.2 million, which represents growth of 9.7%, or $70.6 million, compared to the fourth quarter of 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $74.5 million, an increase of 10.2% compared to the fourth quarter of 2018. By segment, the Clinical Research segment generated revenues of $725.1 million, while the Data Solutions segment generated revenues of $75.1 million.

Direct costs, exclusive of depreciation and amortization, were $386.1 million during the three months ended December 31, 2019 compared to $365.7 million for the three months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased by $24.7 million compared to the fourth quarter of 2018. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 48.2% of revenue during the fourth quarter of 2019 compared to 50.1% of revenue during the fourth quarter of 2018.

Selling, general and administrative expenses were $103.5 million during the three months ended December 31, 2019 compared to $96.4 million for the three months ended December 31, 2018. Selling,

general and administrative costs were 12.9% of revenue during the fourth quarter of 2019 compared to 13.2% of revenue during the fourth quarter of 2018.

GAAP net income attributable to PRA was $74.8 million for the three months ended December 31, 2019, or $1.16 per share on a diluted basis, compared to $71.5 million for the three months ended December 31, 2018, or $1.07 per share on a diluted basis.

EBITDA was $124.9 million for both the three months ended December 31, 2019 and December 31, 2018. Adjusted EBITDA was $148.5 million for the three months ended December 31, 2019, representing growth of 9.0% compared to the three months ended December 31, 2018.

Adjusted net income was $98.7 million for the three months ended December 31, 2019, representing 13.6% growth compared to the three months ended December 31, 2018. Adjusted net income for the three months ended December 31, 2019 includes the effects of a reduction in our effective tax rate from 24% to 23%. The decrease in our effective tax rate is primarily attributable to the geographic distribution of our pre-tax earnings. Adjusted net income per diluted share was $1.54 for the three months ended December 31, 2019, representing 17.6% growth compared to the three months ended December 31, 2018.

Full Year 2019 Financial Highlights

For the twelve months ended December 31, 2019, revenue was $3,066.3 million, which represents growth of 6.8%, or $194.3 million, compared to the twelve months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $225.2 million, representing growth of 7.8% compared to the twelve months ended December 31, 2018. By segment, the Clinical Research segment generated revenues of $2,813.0 million, while the Data Solutions segment generated revenues of $253.3 million.

GAAP income from operations was $363.9 million. GAAP net income attributable to PRA was $243.0 million, or $3.68 per share on a diluted basis, for the twelve months ended December 31, 2019.

Adjusted net income was $341.0 million for the twelve months ended December 31, 2019, an improvement of 20.0% compared to the twelve months ended December 31, 2018. Adjusted net income per diluted share was $5.17 for the twelve months ended December 31, 2019, up 20.8% compared to the twelve months ended December 31, 2018.

Full Year 2020 and Q1 2020 Guidance

For full year 2020, the Company expects to achieve total revenues between $3.23 billion and $3.36 billion, representing as reported and constant currency growth of 5.0% to 9.5%.

We expect GAAP net income per diluted share of between $4.01 and $4.21 per share and adjusted net income per diluted share of between $5.77 and $5.97 per share, representing growth of 12% to 15%. We anticipate an annual effective income tax rate estimate of 23%.

Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

For Q1 2020, the Company expects to achieve total revenues between $765.0 million and $787.0 million, representing as reported and constant currency growth of 6% to 9%. The Company expects GAAP net

income per diluted share of between $0.59 and $0.69 per share, adjusted net income per diluted share between $1.05 and $1.15 per share, and an annual effective income tax rate of 23%.

Our 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30 with all other foreign currencies using a rate as of January 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share and our 2020 guidance, to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on February 21, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 5667733. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 5667733.

Additional Information

A financial supplement with fourth quarter 2019 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q4 2019 Earnings Presentation."

Corcept Therapeutics Announces Fourth Quarter And Full-Year 2019 Audited Financial Results And Provides Corporate Update

On February 20, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended December 31, 2019 (Press release, Corcept Therapeutics, FEB 20, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2 [SID1234554559]).

Financial Highlights

2019 revenue of $306.5 million, an increase of 22 percent from 2018
Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
Fully diluted 2019 GAAP net income of $0.77 per share, compared to $0.60 in 2018
Fully diluted fourth quarter GAAP net income of $0.24 per share, compared to $0.18 in 2018
Year-end cash and investments of $315.3 million, compared to $206.8 million at year-end 2018
Reiterated 2020 revenue guidance of $355 – 375 million
Financial Results

Corcept’s 2019 revenue was $306.5 million, compared to $251.2 million in 2018. Fourth quarter revenue was $87.9 million, compared to $66.8 million in the fourth quarter of 2018. The company reiterated its 2020 revenue guidance of $355 – 375 million.

GAAP net income was $94.2 million for the year and $29.4 million in the fourth quarter of 2019, compared to $75.4 million for the year and $22.0 million in the fourth quarter of 2018.

Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $40.3 million in the fourth quarter, compared to $30.4 million in the fourth quarter of 2018. For the full-year, non-GAAP net income was $133.3 million, compared to $108.2 million in 2018. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

"Our Cushing’s syndrome business had an excellent 2019," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer, "and we expect growth to continue in 2020, as more patients with Cushing’s syndrome receive Korlym and the number of first-time and repeat prescribers of the medication continues to increase.

"Our commercial success has given us the financial resources to advance our portfolio of selective cortisol modulators. By year-end, we plan to be testing three of our proprietary compounds in Phase 2 or Phase 3 trials in Cushing’s syndrome, ovarian cancer, pancreatic cancer, adrenal cancer, antipsychotic-induced weight gain (APIWG) and non-alcoholic steatohepatitis (NASH)."

Cushing’s Syndrome

Phase 3 trial (GRACE) of relacorilant to treat patients with Cushing’s syndrome actively enrolling patients at sites in the United States, Europe and Israel
Phase 3 trial (GRADIENT) of relacorilant to treat patients with Cushing’s syndrome caused by adrenal adenomas expected to start in first quarter
"GRACE is open at fifty-four clinical sites," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Our investigators are enthusiastic. Patients in relacorilant’s Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing’s syndrome’s most pernicious manifestations – as well as in important secondary endpoints, without instances of Korlym’s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.1 For these physicians, whose patients have few good treatment options, the prospect of confirming these data in a pivotal trial is exciting. As we have said, we plan to complete GRACE in time to submit our NDA in the fourth quarter of 2021.

"Our preparations for opening a double-blind, placebo-controlled, Phase 3 trial (GRADIENT) in patients with Cushing’s syndrome caused by adrenal adenomas are nearly complete," added Dr. Grauer. Despite having poor health outcomes, patients with this etiology of Cushing’s syndrome have not been rigorously studied." GRADIENT is expected to enroll 130 patients at sites in the United States and Europe. Many of the clinical sites participating in GRADIENT are already participating in GRACE.

Metabolic Disease

Phase 2 trial of miricorilant to reverse recent APIWG actively enrolling patients
Phase 2 trials of miricorilant to reverse long-standing APIWG and to treat patients with NASH
planned to start in fourth quarter
"The exciting recent developments in our program in metabolic disorders build on years of work," said Dr. Grauer. "We know from data with mifepristone that cortisol modulation has the potential to treat APIWG2 and NASH. Both of these serious disorders afflict millions of people. Last year, our Phase 1b trial showed that our selective cortisol modulator miricorilant at 600 mg was active in mitigating weight gain in healthy volunteers administered olanzapine. Next quarter, we will have results from a 900 mg dose cohort. Our double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with schizophrenia and recent APIWG is now actively enrolling. By year-end, we plan to start testing an improved formulation of miricorilant in two double-blind, placebo-controlled Phase 2 trials – one in patients with long-standing APIWG and another in patients with NASH.

Solid Tumors

Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel to treat metastatic ovarian cancer actively enrolling patients at sites in the United States and Europe, on track to produce results in first half of 2021
Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer
to start in second quarter
Phase 1b trial of relacorilant plus the immunotherapeutic agent pembrolizumab (Keytruda) to treat patients with metastatic or unresectable adrenocortical cancer to start in second quarter
"Our oncology program continues to mature," said Dr. Grauer. "At the American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) annual meeting last June, we presented striking results from our open-label, Phase 1/2 trial of relacorilant plus nab-paclitaxel in patients with ovarian and pancreatic cancers.3 We are seeking to confirm those findings. Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel is actively enrolling patients with metastatic ovarian cancer at 22 sites in the United States and Europe. We expect results in the first half of 2021. Next quarter, we plan to begin a Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer. Our trial design reflects guidance we have received from the FDA and may enable accelerated approval.

"In the second quarter, we plan to start a Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab to treat metastatic or unresectable adrenal cancer, a disease with a very poor prognosis. Patients with adrenal cancer often suffer from Cushing’s syndrome. Our hypothesis is that by modulating the effects of cortisol, relacorilant can alleviate the symptoms of Cushing’s syndrome and, by countering the immunosuppressive effect of cortisol activity, help pembrolizumab achieve its full effect.

"Finally, we expect to conclude by year-end the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

Conference Call

We will hold a conference call on February 20, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call (passcode 7085899). A replay will be available through March 5, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 7085899).