CombiMatrix Corporation Reports Second Quarter 2016 Financial and Operating Results

On August 03, 2016 CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, reported financial results for the three and six months ended June 30, 2016, and provided a business update (Press release, CombiMatrix, AUG 3, 2016, View Source [SID:1234514235]).

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"During the second quarter we made excellent progress toward our goal of achieving profitability with revenue growth, expanded gross margin, improved cash collections and a narrowed operating loss," said Mark McDonough, CombiMatrix President and CEO. "Diagnostic services revenues grew 21%, driven by a 32% increase in reproductive health revenues reflecting increased average revenue per test for miscarriage analysis and prenatal testing.

"We are prudently managing expenses while focusing on our commercial organization to support continued growth," Mr. McDonough added. "Our operating expenses increased by 5% on 22% total revenue growth and we achieved record cash reimbursement of $3 million, representing 95% of total revenues. We also are reporting an 840 basis point improvement in gross margin to 53%, our second consecutive quarter of gross margin above 50%.

"We expect improved financial and operational performance throughout 2016 and 2017 with continued growth in revenue and test volume, along with consistent cash reimbursement and prudent expense management," added Mr. McDonough. "Given our current outlook, we expect to reach positive cash flow from operations by the fourth quarter of 2017."

Second Quarter Financial and Operating Highlights (all comparisons are with the second quarter of 2015)

Total revenues of $3.1 million, up 22%
Reproductive health revenues of $2.2 million, up 32%
Total test volume of 2,780, up 7%
Reproductive health test volume of 1,403, up 9%
Gross margin of 53.0%, up 840 basis points
Number of billable customers of 261, up 16.5%
Number of customers sending 50 or more tests reaching 10, up 100%
Cash collections of 95% of total revenue to $3.0 million, up 21%

Volumes Revenues (in 000’s) Average Revenue / Test
Q2 ’16 Q2 ’15 # Δ % Δ Q2 ’16 Q2 ’15 $ Δ % Δ Q2 ’16 Q2 ’15 $ Δ % Δ
Prenatal 302 340 (38 ) (11 %) $ 472 $ 424 $ 48 11 % $ 1,566.41 $ 1,247.76 $ 319 26 %
Miscarriage analysis 901 916 (15 ) (2 %) 1,457 1,190 267 22 % $ 1,616.72 $ 1,299.32 $ 317 24 %
PGS 200 30 170 567 % 252 42 210 500 % $ 1,258.55 $ 1,389.17 $ (131 ) (9 %)
Subtotal – reproductive health 1,403 1,286 117 9 % 2,181 1,656 525 32 % $ 1,554.84 $ 1,287.78 $ 267 21 %
Pediatric 497 581 (84 ) (14 %) 558 630 (72 ) (11 %) $ 1,121.83 $ 1,083.59 $ 38 4 %
Subtotal – all arrays 1,900 1,867 33 2 % 2,739 2,286 453 20 % $ 1,441.57 $ 1,224.24 $ 217 18 %
Non-array tests 880 732 148 20 % 310 238 72 30 % $ 352.27 $ 325.14 $ 27 8 %
Total – all tests 2,780 2,599 181 7 % 3,049 2,524 525 21 % $ 1,096.90 $ 971.23 $ 126 13 %
Royalties 58 25 33 132 %
Total revenues $ 3,107 $ 2,549 $ 558 22 %

Percentage of arrays 68.3 % 71.8 % 89.8 % 90.6 %


Volumes Revenues (in 000’s) Average Revenue / Test
6 Mo’s. ’16 6 Mo’s. ’15 # Δ % Δ 6 Mo’s. ’16 6 Mo’s. ’15 $ Δ % Δ 6 Mo’s. ’16 6 Mo’s. ’15 $ Δ % Δ
Prenatal 566 664 (98 ) (15 %) $ 794 $ 847 $ (53 ) (6 %) $ 1,403.13 $ 1,274.86 $ 128 10 %
Miscarriage analysis 1,896 1,798 98 5 % 3,079 2,322 757 33 % $ 1,623.76 $ 1,291.57 $ 332 26 %
PGS 367 30 337 1123 % 473 40 433 1083 % $ 1,290.67 $ 1,324.00 $ (33 ) (3 %)
Subtotal – reproductive health 2,829 2,492 337 14 % 4,346 3,209 1,137 35 % $ 1,536.41 $ 1,287.50 $ 249 19 %
Pediatric 949 1,048 (99 ) (9 %) 1,058 1,128 (70 ) (6 %) $ 1,114.41 $ 1,076.74 $ 38 3 %
Subtotal – all arrays 3,778 3,540 238 7 % 5,404 4,337 1,067 25 % $ 1,430.41 $ 1,225.11 $ 205 17 %
Non-array tests 1,650 1,404 246 18 % 575 474 101 21 % $ 348.48 $ 337.61 $ 11 3 %
Total – all tests 5,428 4,944 484 10 % 5,979 4,811 1,168 24 % $ 1,101.52 $ 973.19 $ 128 13 %
Royalties 100 67 33 49 %
Total revenues $ 6,079 $ 4,878 $ 1,201 25 %
Percentage of arrays 69.6 % 71.6 % 90.4 % 90.1 %

Financial Results

Three Months Ended June 30, 2016 and 2015

Total revenues for the second quarter of 2016 increased 22% to $3.1 million from $2.5 million for the second quarter of 2015. Revenues for the second quarter of 2016 were comprised of $3.05 million of diagnostic services revenue and $58,000 in royalties. Reproductive health diagnostic test revenue, which includes prenatal microarrays, miscarriage analysis and PGS, increased 32% to $2.2 million and related testing volumes increased 9% to 1,403. The second quarter 2016 revenue increase was driven primarily by higher average revenue per test particularly for miscarriage analysis and prenatal microarray tests, as well as by an increase in the number of billable customers.

Total operating expenses were $4.3 million for the second quarter of 2016 compared with $4.1 for the prior year period. The increase was due primarily to higher general & administrative expenses from increased severance and bonus accruals, an increase in research & development expenses due to development and launch of new diagnostic testing platforms, and higher cost of services as a result of higher test volume. Gross margin for the second quarter of 2016 improved to 53.0% from 44.6% for the second quarter of 2015.

The net loss attributable to common stockholders for the second quarter of 2016 was $1.2 million, or $0.89 per share, improved by $377,000 from a net loss attributable to common stockholders for the second quarter of 2015 of $1.6 million, or $1.91 per share.

Six Months Ended June 30, 2016 and 2015

Total revenues for the first six months of 2016 increased 25% to $6.1 million from $4.9 million for the first six months of 2015. Revenues for the first six months of 2016 included $6.0 million in diagnostic services revenue and $100,000 in royalty revenues.

Operating expenses for the first six months of 2016 were $8.8 million compared with $8.2 million from the prior-year period, with the increase mainly due to higher cost of services resulting from increased testing volumes. Gross margin improved to 52.3% for the first six months of 2016 from 45.4% for the first six months of 2015.

The net loss attributable to common stockholders for the first six months of 2016 was $4.4 million, or $3.89 per share, compared to $4.3 million, or $5.23 per share in 2015. The higher net loss attributable to common stockholders in 2016 reflected one-time, non-cash charges of $1.9 million related to deemed dividends from the issuance of Series F convertible preferred stock and warrants in the $8.0 million public offering that closed on March 24, 2016. This increase was partially offset by the reversal of the $890,000 Series E deemed dividend recognized in 2015 from the repurchase of those securities upon closing of our public offering, partially reduced by the $656,000 deemed dividend paid to the Series E investors in February of 2016.

The Company reported $5.2 million in cash, cash equivalents and short-term investments as of June 30, 2016, compared with $3.9 million as of December 31, 2015. The Company used $0.9 million and $2.5 million in cash to fund operating activities during the quarter and six months ended June 30, 2016, respectively, compared with $1.5 million and $2.6 million used to fund operating activities during the comparable 2015 periods, respectively. The significant decreases in net cash used to fund operating activities for the 2016 periods resulted primarily from improved cash reimbursement of $3.0 million and $5.4 million for the three and six months ended June 30, 2016, respectively, compared with $2.5 million and $4.6 million for the three and six months ended June 30, 2015, respectively.

Dr. Reddy’s completes acquisition of product portfolio from TEVA

On August 3, 2016 Dr. Reddy’s Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) reported that it successfully completed the previously announced acquisition of eight Abbreviated New Drug Applications (ANDAs) in the U.S. from Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) and an affiliate of Allergan plc (NYSE: AGN) (Press release, Dr Reddy’s, AUG 3, 2016, View Source [SID:1234514225]). The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan’s generics business.

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The portfolio being acquired is a mix of six ANDAs pending approval, one approved ANDA and one ANDA with tentative approval, and comprises complex generic products across diverse dosage forms. The combined sales of the branded versions of the products in the U.S. is approximately $3.5 billion MAT for the most recent twelve months ending in June 2016 according to IMS Health*. The products include Buprenorphine HCl/Naloxone HCl Sublingual Film (generic equivalent to Suboxone sublingual film), Ethinyl estradiol/Ethonogestrel Vaginal Ring (generic equivalent to NuvaRing), Ezetimibe/Simvastatin Tablets (generic equivalent to Vytorin), Metformin HCl/Saxagliptin ER Tablets (generic equivalent to Kombiglyze XR), Tobramycin Inhalation Solution (generic equivalent to Tobi), Phentermine HCl/Topiramate ER Capsules (generic equivalent to Qsymia), Imiquimod Topical Cream (generic equivalent to Zyclara 3.75% Cream), and Ramelteon Tablets (generic equivalent to Rozerem).

*IMS National Sales Perspectives: Retail and Non-Retail MAT June 2016

Vitae Pharmaceuticals Reports Second Quarter 2016 Operating and Financial Results

On August 3, 2016 Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, reported its operating and financial results for the quarter ended June 30, 2016 (Press release, Vitae Pharmaceuticals, AUG 3, 2016, View Source;p=irol-newsArticle&ID=2192602 [SID:1234514222]).

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Jeff Hatfield, President and Chief Executive Officer of Vitae, commented, "During the quarter, we made significant progress towards the completion of two key milestones for Vitae. First, we are on track to report top-line results for the ongoing Phase 2a proof-of-concept study for VTP-38543, our wholly owned, potential first-in-class LXRβ selective agonist being developed for atopic dermatitis, in the fourth quarter of 2016. Second, we continue to finalize plans for the next clinical trial, expected to initiate in the fourth quarter of 2016, of VTP-43742, our wholly owned, first-in-class RORyt inhibitor, in psoriasis patients. Previously, VTP-43742 demonstrated results that validated RORyt as a therapeutic target for psoriasis and VTP-43742 as a potentially paradigm-changing therapeutic."

Quarterly and Recent Highlights

Pipeline Updates:

VTP-38543 in Atopic Dermatitis

Continued enrollment in its Phase 2a proof-of-concept clinical trial of VTP-38543 in atopic dermatitis. This four-week, randomized, double-blind, placebo-controlled Phase 2a trial will assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple ascending topical doses of VTP-38543 in approximately 100 adult patients with mild to moderate atopic dermatitis. Vitae expects to report top-line efficacy results in the fourth quarter of 2016.
VTP-43742 in Autoimmune Disorders

Continued preparations for an upcoming Phase 2 clinical trial of VTP-43742 in psoriasis patients. Vitae plans to advance VTP-43742 into a 16-week Phase 2 trial in the fourth quarter of 2016 with the objectives of: (1) assessing the 16-week efficacy of VTP-43742 in moderate to severe psoriasis patients; (2) assessing the safety of the product candidate in a larger population and over a longer treatment period; and (3) positioning VTP-43742 to begin pivotal trials as soon as practicable after the completion of the Phase 2 clinical trial, if successful. Vitae expects to report top-line data from this trial in the second half of 2017.
VTP-45489 in Autoimmune Disorders

Vitae is advancing VTP-45489, its second RORyt inhibitor, into the clinic. Vitae expects to initiate a Phase 1 single ascending dose clinical trial in normal healthy volunteers during the third quarter of 2016.
New Contour Program

Animal proof-of-principle achieved in a new target program. Initial lead candidate selected to advance into preclinical development.
Corporate Update:

Appointed Carole Sable, M.D., as Chief Medical Officer. Dr. Sable will oversee the clinical development of Vitae’s pipeline, including VTP-43742 and VTP-38543. Dr. Sable brings to Vitae more than 20 years of diverse clinical development and executive management experience, having been involved in all phases of clinical research.

Appointed Daniel M. Junius to Vitae’s Board of Directors. Mr. Junius recently retired as President and Chief Executive Officer of ImmunoGen, Inc. and brings both executive and prior board experience to Vitae’s Board of Directors.
Financial Results:

Operating Expense. Total operating expenses for the second quarter of 2016 were $10.5 million, compared with $10.0 million for the second quarter of 2015.
Research and development expenses were $7.9 million for the second quarter of 2016, compared with $7.8 million for the second quarter of 2015. The slight increase was largely attributable to expenses related to preclinical programs, the atopic dermatitis program, discovery efforts, stock-based compensation and compensation expense, partially offset by reduced manufacturing expenses resulting from the timing of development activities for the RORyt program.
General and administrative expenses were $2.7 million for the second quarter of 2016, compared with $2.3 million for the second quarter of 2015. The increase was primarily due to an increase in legal fees, patent related expenses, stock-based compensation expense and compensation expenses.

Net Loss. Vitae reported a net loss of $10.4 million, or $0.36 per diluted share, for the second quarter of 2016, compared with a net loss of $9.8 million, or $0.45 per diluted share, for the second quarter of 2015. The increase in net loss was primarily due to the increase in general and administrative expenses.

Cash Position. As of June 30, 2016, Vitae had $77.4 million in cash, cash equivalents and marketable securities, compared with $59.4 million as of December 31, 2015. The increase in cash position was primarily a result of the completion of a follow-on public offering in March 2016, partially offset by cash outflows used in operating activities. Based on its current business plan, Vitae believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its projected operating requirements into the second half of 2018.
Expected Upcoming Events

VTP-38543 in Atopic Dermatitis – Top-line proof-of-concept results from a Phase 2a clinical trial in mild to moderate atopic dermatitis patients in the fourth quarter of 2016.

VTP-43742 in Autoimmune Disorders – Initiation of a 16-week Phase 2 trial in the fourth quarter of 2016.

VTP-45489 in Autoimmune Disorders – Initiation of a Phase 1 single ascending dose trial in the third quarter of 2016.

Geron Corporation Reports Second Quarter 2016 Financial Results and Recent Events

On August 3, 2016 Geron Corporation (Nasdaq:GERN) reported financial results for the three and six months ended June 30, 2016 and recent events (Press release, Geron, AUG 3, 2016, View Source;p=irol-newsArticle&ID=2192600 [SID:1234514221]).

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For the second quarter of 2016, the company reported a net loss of $8.6 million, or $0.05 per share, compared to $9.4 million, or $0.06 per share, for the comparable 2015 period. Net loss for the first six months of 2016 was $17.5 million, or $0.11 per share, compared to $18.7 million, or $0.12 per share, for the comparable 2015 period. The company ended the second quarter of 2016 with $136.4 million in cash and investments and has not incurred any impairment charges on its marketable securities portfolio.

Revenues for the three and six months ended June 30, 2016 were $211,000 and $960,000, respectively, compared to $251,000 and $788,000 for the comparable 2015 periods. Revenues for the three and six month periods ending June 30, 2016 and 2015 included royalty and license fee revenues under various non-imetelstat license agreements.

Total operating expenses for the three and six months ended June 30, 2016 were $9.1 million and $18.9 million, respectively, compared to $9.7 million and $19.7 million for the comparable 2015 periods. Research and development expenses for the three and six months ended June 30, 2016 were $4.6 million and $9.6 million, respectively, compared to $4.8 million and $9.8 million for the comparable 2015 periods. General and administrative expenses for the three and six months ended June 30, 2016 were $4.5 million and $9.3 million, respectively, compared to $4.0 million and $8.6 million for the comparable 2015 periods. Operating expenses for the three and six months ended June 30, 2015 also included restructuring charges of $941,000 and $1.3 million, respectively, in connection with the company’s organizational resizing announced in March 2015.

The decrease in research and development expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects the net result of reduced personnel-related costs resulting from the March 2015 organizational resizing and lower costs for the manufacturing of imetelstat drug product, partially offset by higher costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). The company expects research and development expenses to increase during the remainder of the year as the clinical development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher non-cash stock-based compensation expense and increased allocation of facilities and other overhead costs to general and administrative activities.

Interest and other income for the three and six months ended June 30, 2016 was $293,000 and $549,000, respectively, compared to $145,000 and $294,000 for the comparable 2015 periods. The increase in interest and other income for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher yields on the company’s marketable securities portfolio.

Recent Company Events

In July 2016, three U.S. patents related to imetelstat were issued by the U.S. Patent and Trademark Office. U.S. 9,375,485 has claims covering the use of telomerase inhibitor compounds, including imetelstat, for alleviating at least one symptom of myelofibrosis or myelodysplastic syndromes, including chronic myelomonocytic leukemia, and is expected to remain in force until at least March 2033. U.S. 9,388,415 and U.S. 9,388,416 have claims covering methods for using imetelstat to inhibit the activity of telomerase and using imetelstat to inhibit cancer cell proliferation, as well as methods for using imetelstat to treat cancer, and are expected to remain in force until at least September 2024. These patents are related to Geron’s existing imetelstat composition of matter patent U.S. 7,494,982, which issued in 2009 and is expected to remain in force until at least December 2025. Further extension of patent terms may be available for regulatory review periods.

Geron’s portfolio of patents related to imetelstat and related products whose mechanism of action is telomerase inhibition have been licensed to Janssen under an exclusive worldwide license and collaboration agreement for all human disorders or medical conditions.

Synthetic Biologics Reports Second Quarter 2016 Operational Highlights and Financial Results

On August 3, 2016 Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, reported an operational update and reported financial results for the three months ended June 30, 2016(Press release, Synthetic Biologics, AUG 3, 2016, View Source [SID:1234514220]).

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Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)
"In the second quarter we continued the transition from an early-stage clinical development company to a late-stage clinical development company focused on the commercialization of our two lead GI microbiome-focused drug candidates," said Jeffrey Riley, Chief Executive Officer. "We held an End of Phase 2 meeting with FDA and received guidance for advancement to a pivotal clinical trial for SYN-010, designed to treat an underlying cause of the symptoms associated with irritable bowel syndrome with constipation (IBS-C)." Mr. Riley continued, "The approval of the generic name ‘ribaxamase’ for SYN-004, the announcement of positive clinical outcomes from a second Phase 2a clinical trial and robust enrollment in our global Phase 2b proof-of-concept clinical trial continued to fuel momentum for our program designed to protect the gut microbiome and prevent C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic resistant organisms. To date, we have enrolled 374 patients and anticipate announcing topline results from our ongoing Phase 2b clinical trial for SYN-004 in early 2017."

Microbiome-Focused Clinical Program Progress

SYN-010 – Treatment of irritable bowel syndrome with constipation (IBS-C):

Held End of Phase 2 meeting with FDA and received guidance for clinical study design and requirements for Phase 3 development
Plan to initiate Phase 2b/3 pivotal clinical trial (1Q 2017)
Presented detailed data during Digestive Disease Week 2016 supporting previously reported positive outcomes from two Phase 2 clinical trials of SYN-010, including:
Data demonstrating an inverse correlation between breath methane Area Under Curve (AUC) and complete spontaneous bowel movements (CSBMs) in study participants diagnosed with IBS-C
Data demonstrating clear improvements in abdominal pain, bloating and quality of life measures (IBS-SSS) in study participants who were administered SYN-010
Announced results from a separate randomized, open-label Pharmacokinetic (PK) study demonstrating SYN-010 avoided desired drug release in the stomach and delivered the antimethanogenic lovastatin lactone into the lower small intestine and colon while reducing systemic exposure to the cholesterol-lowering lovastatin beta-hydroxyacid metabolite

SYN-004 (ribaxamase) – Prevention of CDI, AAD and the emergence of antibiotic-resistant organisms:

Received approval from United States Adopted Names Council (USAN) for the generic name "ribaxamase" for SYN-004
Continued enrollment in global Phase 2b proof-of-concept clinical trial intended to evaluate the ability of ribaxamase to prevent CDI, C. difficile-associated diarrhea (CDAD) and AAD in patients hospitalized with a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone
Enrolled 374 patients to date across global clinical sites; enrollment expected through 3Q 2016
Anticipate announcing topline results from Phase 2b proof-of-concept clinical trial (1Q 2017)
Announced positive results from second Phase 2a clinical trial demonstrating a correlation of the 150 mg dose of ribaxamase, both alone and in the presence of the proton pump inhibitor, esomeprazole and the successful degradation of IV ceftriaxone to levels that were near or below detectable without impacting ceftriaxone plasma concentrations
The 150 mg dose strength of ribaxamase was well tolerated by all participants
Operational Update – Expanded Leadership Team

Deb Mathews, PharmD, joined the Company as Vice President, Medical Affairs, bringing broad experience and strong leadership of clinical and medical affairs as the Company begins to implement commercialization strategies
Isaac J. Bright, MD, joined the Company in the newly created position of Vice President, Corporate Development, to lead all strategic corporate and business development efforts for the Company’s two lead microbiome-focused drug candidates
Second Quarter 2016 Financial Results

General and administrative expenses decreased by 3% to $2.1 million for the second quarter of 2016, from $2.2 million for the second quarter of 2015. This decrease is primarily the result of lower legal fees offset by an increase in stock-based compensation and increased employee costs associated with the transition of the administrative and financial office to our Maryland headquarters. The charge related to stock-based compensation expense was $507,000 for the second quarter of 2016, compared to $335,000 for the second quarter of 2015.

Research and development expenses decreased by 5% to $7.2 million for the second quarter of 2016, from $7.5 million for the second quarter of 2015. This decrease is primarily the result of decreased Phase 2 program costs associated with clinical development programs, manufacturing and research activities within our microbiome-focused pipeline. Research and development expenses also include a charge related to non-cash stock-based compensation expense of $400,000 for the second quarter of 2016, compared to $252,000 for the second quarter of 2015.

Other income was $3.5 million for the second quarter of 2016, compared to other expense of $3.9 million for the second quarter of 2015. Other income for the second quarter of 2016 is due to non-cash expense of $3.5 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the year ended December 31, 2015. Non-cash expense related to the increase of fair value of warrants for the second quarter of 2015 was $3.9 million.